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Software Process Standards

Introduction

This page listed "Software Process Standards” for the following processes, Configuration Management, Documentation, Function Points, Human Factors, Integration, Maintenance, Medical Devises, Project Management, Quality, Requirement Definition, Safety, Test, Validation and Verification". These standards are listed by producers. This page also list the best-selling standards of this grouping. This allows a person to look at what other software developers are using for their product. Also on this page is a menu by type. If a viewer wants to buy a standard he/she need only to click on the buy button on the right hand side and they will be directed to IHS our partners for supplying the product.

Software Configuration Management
Standards
The best software processes standards for Configuration
Management by producer
BSI BSI

BS 7738-1 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Specification for Information Systems Products Using SSADM--(Structured Systems Analysis and Design Method)

Published By: British Standards Institution (BSI)

Page Count: 146

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BSI BSI

EIA 649(Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Configuration Management Standard

Published By: SAE International (SAE)

Page Count: 85

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BSI BSI

IEEE 828 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Software Configuration Management Plans

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg: REAF     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-Software life cycle processes Systems and software engineering-Software

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BSI BSI

ISO/IEC 15288:2008 (Complete Document)

Revision / Edition: 2ND    Chg: REAF     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-System life cycle processes

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ISO/IEC TR 18018 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 02/15/10   Abbreviations Definitions

Active, Most Current

Software Engineering-Software Life Cycle-- Guide for configuration management tool capabilities

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BSI BSI

ISO/IEC TR 24748-1 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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Software Design Standards
The best software processes standards for Software Design,
by producer.
BSI BSI

ANS ANSI/IEEE 7- 4.3.2 (Complete Document)

Revision / Edition: 10    Chg: REAF     Date: 06/07/10   Abbreviations Definitions

Active, Most Current

Application Criteria for Programmable Digital Computer Systems in Safety Systems of Nuclear Power Generating Stations

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BSI BSI

ANSI/UL 1998 (Complete Document)

Revision / Edition: 3    Chg: REAF     Date: 12/18/13   Abbreviations Definitions

Active, Most Current

Software in Programmable Components, Second Edition

Published By: UL (UL)

Page Count: 38

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BSI BSI

BS 7738-1 (Complete Document)

Revision / Edition: 94    Chg: REAF     Date: 11/01/12   Abbreviations Definitions

Active, Most Current

Specification for Information Systems Products Using SSADM--
(Structured Systems Analysis and Design Method)

Published By: British Standards Institution (BSI)

Page Count: 146

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BSI BSI

IEC 60601-1 (Complete Document)

Revision / Edition: 3.1    Chg: COR1     Date: 07/00/14   Abbreviations Definitions

Active, Most Current

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Published By: International Electrotechnical Commission (IEC)

Page Count: 428

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BSI BSI

IEC 60880 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 05/00/06   Abbreviations Definitions

Active, Most Current

Software for Computers in the Safety Systems of Nuclear Power Stations

Published By: International Electrotechnical Commission (IEC)

Page Count: 226

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BSI BSI

IEC 62304 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Medical device software - Software life cycle processes

Published By: (SEPT)

Page Count: 0

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BSI BSI

IEEE 1016 (Complete Document)

Revision / Edition:    Chg:     Date: 03/19/09    Abbreviations Definitions

Active, Most Current

Recommended Practice for Software Design Descriptions

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BSI BSI

IEEE 1074 (Complete Document)

Revision / Edition: 06   Chg: REAF     Date: 03/30/06   Abbreviations Definitions

Active, Most Current

Standard for Developing Software Project Life Cycle Processes

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BSI BSI

IEEE 1220 (Complete Document)

Revision / Edition: 05    Chg:     Date: 03/20/05   Abbreviations Definitions

Active, Most Current

Standard for Application and Management of the System Engineering Process

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BSI BSI

IEEE 16085 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Software Life Cycle Processes - Risk Management

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-Software life cycle processes

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BSI BSI

ISO/IEC 14102 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Guideline for the Evaluation and Selection of CASE Tools

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BSI BSI

ISO/IEC 15288:2008 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

Systems and software engineering-System life cycle processes

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BSI BSI

ISO/IEC TR 24748-1 (Complete Document)

Revision / Edition: 1ST   Chg:     Date: 10/01/10   Abbreviations Definitions

Active, Most Current

Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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BSI BSI

ISO/IEC 29110-4-1 (Complete Document)

Revision / Edition:1ST    Chg:     Date: 01/15/11   Abbreviations Definitions

Active, Most Current

Software engineering - Lifecycle profiles for Very Small Entities (VSEs) - Part 4-1: Profile specifications: Generic profile group

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BSI BSI

IEEE/ISO/IEC 42010 (Complete Document)

Revision / Edition: 1ST   Chg:     Date: 12/01/11   Abbreviations Definitions

Active, Most Current

Systems and software engineering -- Architecture description

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BSI BSI

SAE J2640 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/15/09   Abbreviations Definitions

Active, Most Current

General Automotive Embedded Software Design Requirements

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Software Documentation Standards
The best software processes standards for Software
Documentation Standards, by producer.
BSI BSI

BS 7649 (Complete Document)

Revision / Edition: 12    Chg:     Date: 03/31/12   Abbreviations Definitions

Active, Most Current

The Design and Preparation of Documentation for Users of Application S/W

Published By: British Standards Institution (BSI)

Page Count: 102

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BSI BSI

IEC 60880 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 05/0/06   Abbreviations Definitions

Active, Most Current

Software for Computers in the Safety Systems of Nuclear Power Stations

Published By: International Electrotechnical Commission (IEC)

Page Count: 226

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BSI BSI

IEC 61506 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 02/0/97   Abbreviations Definitions

Active, Most Current

Industrial-process measurement and control - Documentation of application software

Published By: International Electrotechnical Commission (IEC)

Page Count: 129

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BSI BSI

IEC 62304 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

Active, Most Current

Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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BSI BSI

IEEE 829 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

Active, Most Current

Software Test Documentation

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BSI BSI

IEEE 1016 (Complete Document)

Revision / Edition: 09    Chg:     Date: 03/19/09   Abbreviations Definitions

Active, Most Current

Recommended Practice for Software Design Descriptions

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BSI BSI

IEEE 1074 (Complete Document)

Revision / Edition: 06    Chg:     Date: 03/30/06   Abbreviations Definitions

Active, Most Current

Standard for Developing Software Project Life Cycle Process

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

Active, Most Current

Systems and software engineering-Software life cycle processes

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BSI BSI

ISO/IEC 15288:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-System life cycle processes

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BSI BSI

ISO/IEC/IEEE 15289 (Complete Document)

Revision / Edition: 1ST   Chg:     Date: 11/01/11   Abbreviations Definitions

Active, Most Current

ISO/IEC/IEEE Systems and software engineering -- Content of life-cycle information products (documentation)

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BSI BSI

ISO/IEC 19770-1 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 06/15/12   Abbreviations Definitions

Active, Most Current

Information Technology- Software Asset Management -Part 1 Processes

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BSI BSI

ISO/IEC 19770-2 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/15/09   Abbreviations Definitions

Active, Most Current

Information technology -- Software asset management -- Part 2: Software identification tag

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BSI BSI

ISO/IEC 26511 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

Active, Most Current

Requirements for managers of user documentation

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BSI BSI

BS ISO/IEC 26512 (Complete Document)

Revision / Edition: 11    Chg:     Date: 07/31/11   Abbreviations Definitions

Active, Most Current

Requirements for acquirers and suppliers of user documentation

Published By: British Standards Institution (BSI)

Page Count: 52

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BSI BSI

ISO/IEC 26513 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 10/15/09   Abbreviations Definitions

Active, Most Current

Systems and software engineering - Requirements for testers and reviewers of user documentation

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BSI BSI

ISO/IEC 26514 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 06/15/08   Abbreviations Definitions

Active, Most Current

Requirements for designers and developers of user documentation

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Function Point Standards
The best software processes standards for Function
Point Standards, by producer
BSI BSI

ISO/IEC 14143-1 (Complete Document)

Revision / Edition: 2ND    Chg: COR1   Date: 12/01/11   Abbreviations Definitions

Active, Most Current

Software Measurement--Functional Size Measurement-Part1: Definition of Concepts

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BSI BSI

ISO/IEC 14143-2 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 09/01/11   Abbreviations Definitions

Active, Most Current

Software Measurement--Functional Size Measurement-Conformity evaluation of software size measurement methods to ISO/IEC 14143-1:1998

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BSI BSI

ISO/IEC 19761 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 03/15/11   Abbreviations Definitions

Active, Most Current

COSMIC-FFP - A Functional Size Measurement Method

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BSI BSI

ISO/IEC 20926 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 12/01/09   Abbreviations Definitions

Active, Most Current

Software and Systems Engineering - Software measurement - IFPUG functional size measurement method 2009

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BSI BSI

ISO/IEC 20968 (Complete Document)

Revision / Edition: 2    Chg:     Date: 12/01/02   Abbreviations Definitions

Active, Most Current

Mark II Function Point Analysis Counting Manual

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Human Factors Standards
The best software processes standards for Human
Factors, by producer.
BSI BSI

ANSI/AAMI/IEC 62366 (Complete Document)

Revision / Edition: 1.1    Chg:     Date: 01/0/14   Abbreviations Definitions

Active, Most Current

Application of usability engineering to medical devices

Published By: International Electrotechnical Commission (IEC)

Page Count: 442

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BSI BSI

IEEE 2001 (Complete Document)

Revision / Edition: 02    Chg:     Date: 09/12/02   Abbreviations Definitions

Active, Most Current

Recommended Practice for the Internet - Web Site Engineering, Web Site Management, and Web Site Life Cycle

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BSI BSI

ISO 9241-1 (Complete Document)

Revision / Edition: 2ND    Chg:A1     Date: 03/01/01   Abbreviations Definitions

Active, Most Current

Ergonomic Requirements for Office Work with Visual Display Terminals (VDT's) General Introduction

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ISO 9241-2 (Complete Document)

Revision / Edition: 92    Chg:     Date: 06/01/92    Abbreviations Definitions

Active, Most Current

Guidance on Task Requirements

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BSI BSI

ISO 9241-304 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/15/08   Abbreviations Definitions

Active, Most Current

Visual Display Requirements

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BSI BSI

ISO 9241-5 (Complete Document)

Revision / Edition: 98    Chg:     Date: 10/01/98   Abbreviations Definitions

Active, Most Current

Workstation Layout and Postural Requirements

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BSI BSI

ISO 9241-6 (Complete Document)

Revision / Edition: 99    Chg:     Date: 12/01/99   Abbreviations Definitions

Active, Most Current

Environmental Requirements

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BSI BSI

ISO 9241-11 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 03/15/98   Abbreviations Definitions

Active, Most Current

Guidance on Usability

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BSI BSI

ISO 9241-12 (Complete Document)

Revision / Edition: 98    Chg:     Date: 12/01/98   Abbreviations Definitions

Active, Most Current

Presentation of Information

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BSI BSI

ISO 9241-13 (Complete Document)

Revision / Edition: 98    Chg:     Date: 07/15/98   Abbreviations Definitions

Active, Most Current

User Guidance

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BSI BSI

ISO 9241-14 (Complete Document)

Revision / Edition: 97    Chg:     Date: 06/01/97   Abbreviations Definitions

Active, Most Current

Menu Dialogues

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BSI BSI

ISO 9241-15 (Complete Document)

Revision / Edition: 97    Chg:     Date: 12/15/97   Abbreviations Definitions

Active, Most Current

Command Language Dialogues

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BSI BSI

ISO 9241-110 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 04/01/06   Abbreviations Definitions

Active, Most Current

Dialogue Principles

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BSI BSI

ISO 9241-210 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 03/15/10   Abbreviations Definitions

Active, Most Current

Human-centred design for interactive systems

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BSI BSI

ISO 9241-303 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 11/15/11   Abbreviations Definitions

Active, Most Current

Requirements for Electronic Visual Displays

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BSI BSI

ISO TR 9241-411 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

Active, Most Current

Evaluation methods for the design of physical input devices

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BSI BSI

ISO TR 18529 (Complete Document)

Revision / Edition: 0    Chg:     Date: 06/15/0   Abbreviations Definitions

Active, Most Current

Human-centered Lifecycle Process Descriptions

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BSI BSI

ISO/IEC 25040 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 03/01/11   Abbreviations Definitions

Active, Most Current

Systems and software Quality Requirements and Evaluation (SQuaRE) - Evaluation process

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Software Integration Standards
The best software processes standards for Software
Integration by producer.
BSI BSI

BS 7738-1 (Complete Document)

Revision / Edition: 94    Chg:REAF     Date: 11/01/12   Abbreviations Definitions

Active, Most Current

Specification for Information Systems Products Using SSADM--(Structured Systems Analysis and Design Method)

Published By: British Standards Institution (BSI)

Page Count: 146

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BSI BSI

IEC 62304 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 05/0/06   Abbreviations Definitions

Active, Most Current

Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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BSI BSI

IEEE 1012 (Complete Document)

Revision / Edition: 12    Chg:     Date: 03/29/12   Abbreviations Definitions

Active, Most Current

Software Verification and Validation

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BSI BSI

IEEE 1074 (Complete Document)

Revision / Edition: 06    Chg:     Date: 03/30/06   Abbreviations Definitions

Active, Most Current

Standard for Developing a Software Project Life Cycle Process

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BSI BSI

IEEE 1220 (Complete Document)

Revision / Edition: 05    Chg:     Date: 03/20/05   Abbreviations Definitions

Active, Most Current

Standard for Application and Management of the Systems Engineering Process

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BSI BSI

ISO 17894 (Complete Document)

Revision / Edition: 05    Chg:     Date: 03/15/05   Abbreviations Definitions

Active, Most Current

Ships and marine technology - Computer applications - General principles for the development and use of programmable electronic systems in marine applications

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-Software life cycle processes

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BSI BSI

ISO/IEC 14102 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 11/01/08   Abbreviations Definitions

Active, Most Current

Guideline for the Evaluation and Selection of CASE Tools

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BSI BSI

ISO/IEC 14764 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 09/01/06   Abbreviations Definitions

Active, Most Current

Software Engineering - Software Life Cycle Processes - Maintenance

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BSI BSI

ISO/IEC 15288:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-System life cycle processes

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BSI BSI

ISO/IEC 33002 (Complete Document)

Revision / Edition: 1ST    Chg:TCI     Date: 02/15/04   Abbreviations Definitions

Active, Most Current

Information Technology - Process Assessment - Requirements for Performing Process Assessment

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BSI BSI

IEEE/ISO/IEC 16085 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 12/15/06   Abbreviations Definitions

Active, Most Current

Software Life Cycle Processes - Risk Management

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BSI BSI

ISO/IEC TR 24748-1 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 10/01/10   Abbreviations Definitions

Active, Most Current

Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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Software Maintenance Standards
The best software processes standards for Software Maintenance,
by producer.
BSI BSI

ASTM E1578 (Complete Document)

Revision / Edition: 13    Chg:     Date: 08/01/13   Abbreviations Definitions

Active, Most Current

Standard Guide for Laboratory Information Management System

Published By: ASTM International (ASTM)

Page Count: 47

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BSI BSI

BS 7738-1 (Complete Document)

Revision / Edition: 94    Chg: REAF     Date: 11/01/12   Abbreviations Definitions

Active, Most Current

Specification for Information Systems Products Using SSADM--(Structured Systems Analysis and Design Method)

Published By: British Standards Institution (BSI)

Page Count: 146

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BSI BSI

IEC 60880 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 05/0/06   Abbreviations Definitions

Active, Most Current

Software for Computers in the Safety Systems of Nuclear Power Stations

Published By: International Electrotechnical Commission (IEC)

Page Count: 226

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BSI BSI

IEC 62304 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 05/0/06   Abbreviations Definitions

Active, Most Current

Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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BSI BSI

ISO 17894 (Complete Document)

Revision / Edition: 05    Chg:     Date: 03/15/05   Abbreviations Definitions

Active, Most Current

Ships and marine technology - Computer applications - General principles for the development and use of programmable electronic systems in marine applications

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

Active, Most Current

Systems and software engineering-Software life cycle processes

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BSI BSI

ISO/IEC 14764 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 09/01/06   Abbreviations Definitions

Active, Most Current

Software Maintenance

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BSI BSI

ISO/IEC 15504-2 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 02/15/04   Abbreviations Definitions

Active, Most Current

Software Process Assessment-Part 2: A Reference Model for Processes and Process Capability

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BSI BSI

IEEE/ISO/IEC 16085 (Complete Document)

Revision / Edition: 06    Chg:     Date: 0/0/06   Abbreviations Definitions

Active, Most Current

Software Life Cycle Processes - Risk Management

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BSI

ISO/IEC TR 24748-1 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 10/01/10   Abbreviations Definitions

Active, Most Current

Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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BSI BSI

RTCA DO-178 (Complete Document)

Revision / Edition: C    Chg:     Date: 12/13/11   Abbreviations Definitions

Active, Most Current

Software Considerations in Airborne Systems and Equipment Certification

Published By: RTCA, Inc. (RTCA)

Page Count: 144

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Medical Device Standards
The best software processes standards for Medical Devices,
by producer.
BSI BSI

AAMI TIR36 (Complete Document)

Revision / Edition: 07    Chg:     Date: 0/0/07   Abbreviations Definitions

Active, Most Current

Validation of software for regulated processes

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BSI BSI

AAMI TIR45 (Complete Document)

Revision / Edition: 12    Chg:     Date: 0/0/12   Abbreviations Definitions

Active, Most Current

Guidance on the use of agile practices in the development of medical device software

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BSI BSI

ANSI/AAMI/ IEC 62366 (Complete Document)

Revision / Edition: 1.1    Chg:     Date: 01/0/14   Abbreviations Definitions

Active, Most Current

Application of usability engineering to medical devices

Published By: International Electrotechnical Commission (IEC)

Page Count: 442

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BSI BSI

ANSI/AAMI/ISO 13485 (Complete Document)

Revision / Edition: 2ND    Chg: COR1     Date: 08/01/09   Abbreviations Definitions

Active, Most Current

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

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BSI BSI

ANSI/AAMI/ISO 14971 (Complete Document)

Revision / Edition: 02ND    Chg:     Date: 03/01/07   Abbreviations Definitions

Active, Most Current

Risk Management - Part 1: Application of Risk Management to Medical Devices

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UL 1998 (Complete Document)

Revision / Edition: 3    Chg:     Date: 12/18/13   Abbreviations Definitions

Active, Most Current

Software in Programmable Components, Second Edition

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BSI BSI

ASTM E1384 (Complete Document)

Revision / Edition: 07    Chg: W/ REAP     Date: 0/0/13   Abbreviations Definitions

Active, Most Current

Standard Practice for Content and Structure of the Electronic Health Record (EHR)

Published By: ASTM International (ASTM)

Page Count: 115

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BSI BSI

ASTM E1578 (Complete Document)

Revision / Edition: 13    Chg:     Date: 08/01/13   Abbreviations Definitions

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Published By: ASTM International (ASTM)

Page Count: 47

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BSI BSI

FDA 21 CFR 1-99 (Complete Document)

Revision / Edition: 14    Chg:     Date: 04/01/14   Abbreviations Definitions

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Published By: Code of Federal Regulations (CFR) (BERNAN)

Page Count: 0

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BSI BSI

FDA Off-The-Shelf SW (Complete Document)

Revision / Edition: 99    Chg:     Date: 09/09/99   Abbreviations Definitions

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OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES

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BSI BSI

FDA Pre market Submissions (Complete Document)

Revision / Edition: 05    Chg:     Date: 05/11/05   Abbreviations Definitions

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GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES

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BSI BSI

FDA SW Validation (Complete Document)

Revision / Edition: 02    Chg:     Date: 01/11/02   Abbreviations Definitions

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GENERAL PRINCIPLES OF SOFTWARE VALIDATION; FINAL GUIDANCE FOR INDUSTRY AND FDA STAFF

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BSI BSI

IEC 60601-1 (Complete Document)

Revision / Edition: 3.1    Chg: COR1     Date: 07/00/14   Abbreviations Definitions

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Published By: International Electrotechnical Commission (IEC)

Page Count: 428

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BSI BSI

IEC 61508-3 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 04/0/10   Abbreviations Definitions

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Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems - Part 3: Software Requirements

Published By: International Electrotechnical Commission (IEC)

Page Count: 236

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BSI BSI

IEC 62304 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 05/0/06   Abbreviations Definitions

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Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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BSI BSI

IEC 80001-1 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 10/00/10   Abbreviations Definitions

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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

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BSI BSI

ISO 9001:2008 (Complete Document)

Revision / Edition: 4th    Chg: COR1    Date: 07/15/09   Abbreviations Definitions

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Quality Management Systems - Requirements

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BSI BSI

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Revision / Edition: 2ND    Chg: COR1     Date: 07/15/11   Abbreviations Definitions

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Clinical investigation of medical devices for human subjects -- Good clinical practice

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BSI BSI

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Revision / Edition: 1ST    Chg:     Date: 11/01/10   Abbreviations Definitions

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Guidance on Social Responsibility

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BSI BSI

ISO 31000 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/15/09   Abbreviations Definitions

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Risk management - Principles and guidelines

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

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Systems and software engineering-Software life cycle processes

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BSI BSI

ISO/IEC 15026-1 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/01/13   Abbreviations Definitions

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Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary

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BSI BSI

ISO/IEC 15288:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08   Abbreviations Definitions

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Systems and software engineering-System life cycle processes

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BSI BSI

ISO/IEC 27002 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

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Information Technology - Code of Practice for Information Security Management

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BSI BSI

ISO/IEC 90003 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 02/15/04   Abbreviations Definitions

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Software Project Management Standards
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BSI BSI

BS-7738-1 (Complete Document)

Revision / Edition: 94    Chg:     Date: 11/01/12   Abbreviations Definitions

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Published By: British Standards Institution (BSI)

Page Count: 146

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BSI BSI

IEEE 1028 (Complete Document)

Revision / Edition: 08    Chg:     Date: 06/16/08   Abbreviations Definitions

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BSI BSI

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Revision / Edition: 09    Chg:     Date: 11/09/09   Abbreviations Definitions

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BSI BSI

IEEE 1062 (Complete Document)

Revision / Edition: 98    Chg:     Date: 09/11/02   Abbreviations Definitions

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BSI BSI

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Revision / Edition: 06    Chg:     Date: 03/30/06   Abbreviations Definitions

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BSI BSI

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Revision / Edition: 11    Chg:     Date: 10/31/11   Abbreviations Definitions

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BSI BSI

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Revision / Edition: 09    Chg:     Date: 12/15/09   Abbreviations Definitions

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Systems and software engineering -- Life cycle processes -- Project management

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BSI BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 02/01/08    Abbreviations Definitions

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Systems and software engineering-Software life cycle processes

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BSI BSI

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Revision / Edition: 1st    Chg: TC1     Date: 02/15/04   Abbreviations Definitions

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Software Process Assessment-Part 2: A Reference Model for Processes and Process Capability

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BSI BSI

ISO/IEC 15939 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 08/01/07   Abbreviations Definitions

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BSI BSI

IEE/ISO/IEC 16085 (Complete Document)

Revision / Edition: 06    Chg:     Date: 00/00/06   Abbreviations Definitions

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Software Life Cycle Processes - Risk Management

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BSI BSI

ISO/IEC 16326 (Complete Document)

Revision / Edition: 0    Chg:     Date: 0/0/0   Abbreviations Definitions

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Systems and software engineering - Life cycle processes - Project management

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BSI BSI

ISO 19011 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 11/15/11   Abbreviations Definitions

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BSI BSI

ISO/IEC 24748-1 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 10/01/10   Abbreviations Definitions

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Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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BSI BSI

SAE J2746 (Complete Document)

Revision / Edition: 09    Chg:     Date: 04/00/09   Abbreviations Definitions

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Software Assessment Repository

Published By: SAE International (SAE)

Page Count: 18

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Software Quality Standards
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BSI BSI

ANSI/AAMI/ISO 13485 (Complete Document)

Revision / Edition: 2nd    Chg: COR1     Date: 08/01/09   Abbreviations Definitions

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ASME BSI

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Revision / Edition: 12    Chg:     Date: 0/0/12   Abbreviations Definitions

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Published By: ASME International (ASME)

Page Count: 288

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IEC IEC

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Revision / Edition: 2.2    Chg:     Date: 05/00/06   Abbreviations Definitions

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Software for Computers in the Safety Systems of Nuclear Power Stations

Published By: International Electrotechnical Commission (IEC)

Page Count: 226

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IEC IEC

IEC 62304 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 05/00/06   Abbreviations Definitions

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Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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IEEE BSI

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Revision / Edition: 14    Chg:     Date: 03/27/14    Abbreviations Definitions

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IEEE BSI

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Revision / Edition: 05    Chg:     Date: 11/08/05    Abbreviations Definitions

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Standard Dictionary of Measures to Produce Reliable Software

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IEEE BSI

IEEE 1061 (Complete Document)

Revision / Edition: 98    Chg: W/ REAF     Date: 06/24/04   Abbreviations Definitions

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IEEE BSI

IEEE 16085 (Complete Document)

Revision / Edition: 06    Chg:     Date: 0/0/06   Abbreviations Definitions

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Software Life Cycle Processes - Risk Management

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ISO BSI

ISO 9001:2008 (Complete Document)

Revision / Edition: 4th    Chg:COR1     Date: 07/15/09   Abbreviations Definitions

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ISO BSI

ISO 9004:2009 (Complete Document)

Revision / Edition: 3rd    Chg:     Date: 11/01/09   Abbreviations Definitions

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ISO BSI

ISO/IEC 12207:2008 (Complete Document)

Revision / Edition: 2nd    Chg:     Date: 02/01/08   Abbreviations Definitions

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Systems and software engineering-Software life cycle processes

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ISO BSI

ISO/IEC 14102 (Complete Document)

Revision / Edition: 2nd    Chg:     Date: 11/01/08    Abbreviations Definitions

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Guideline For the Evaluation and Selection of CASE Tools

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ISO BSI

ISO/IEC 15026-1 (Complete Document)

Revision / Edition: 1st    Chg:     Date: 11/01/13   Abbreviations Definitions

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Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary

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ISO BSI

ISO/IEC 20000-1 (Complete Document)

Revision / Edition: 2nd    Chg:     Date: 04/15/11   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 1st    Chg:     Date: 08/15/12   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 1st    Chg:     Date: 03/01/11   Abbreviations Definitions

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Quality Requirements and Evaluation (Square)- Evaluation Process

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BSI BSI

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Revision / Edition: 1st    Chg:     Date: 02/15/04   Abbreviations Definitions

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Software Requirements Definition Standards
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IEEE BSI

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Revision / Edition: 10    Chg:     Date: 06/17/10   Abbreviations Definitions

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Application Criteria for Programmable Digital Computer Systems in Safety Systems of Nuclear Power Generating Stations

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ANSI/UL 1998 (Complete Document)

Revision / Edition: 3    Chg:     Date: 12/18/13   Abbreviations Definitions

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Software in Programmable Components, Second Edition

Published By: UL (UL)

Page Count: 38

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ASTM BSI

ASTM E1578 (Complete Document)

Revision / Edition: 13    Chg:     Date: 08/01/13    Abbreviations Definitions

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Standard Guide for Laboratory Information Management System

Published By: ASTM International (ASTM)

Page Count: 47

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ISO BSI

BS 7738-1 (Complete Document)

Revision / Edition: 94    Chg: REAF     Date: 11/01/12   Abbreviations Definitions

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Page Count: 146

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ISO BSI

ISO 17894 (Complete Document)

Revision / Edition: 05    Chg:     Date: 03/15/05   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 2nd    Chg:     Date: 02/01/08   Abbreviations Definitions

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Systems and software engineering-Software life cycle processes

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ISO BSI

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Revision / Edition: 2nd    Chg:     Date: 02/01/08   Abbreviations Definitions

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Systems and software engineering-System life cycle processes

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ISO BSI

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Revision / Edition: 1st    Chg:     Date: 02/15/04   Abbreviations Definitions

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Software Process Assessment- Part 2: A Reference Model for Processes and Process Capability

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ISO BSI

ISO/IEC TR 24766 (Complete Document)

Revision / Edition: 1st    Chg:     Date: 12/15/09   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 1st    Chg:     Date: 10/01/10   Abbreviations Definitions

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Systems and software engineering - Life cycle management - Part 1: Guide for life cycle management

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ISO BSI

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Revision / Edition: 1st    Chg:     Date: 01/15/11   Abbreviations Definitions

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IEEE BSI

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Revision / Edition: 11    Chg:     Date: 0/0/11   Abbreviations Definitions

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Systems and software engineering -- Life cycle processes --Requirements engineering

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RTCA BSI

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Revision / Edition: C    Chg:     Date: 12/13/11   Abbreviations Definitions

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Software Safety Standards
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ISO BSI

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Revision / Edition: 2nd    Chg:     Date: 03/01/07   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 1.1    Chg:     Date: 01/00/14   Abbreviations Definitions

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Page Count: 442

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IEEE BSI

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Revision / Edition: 10    Chg:     Date: 06/17/10   Abbreviations Definitions

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Application Criteria for Programmable Digital Computer Systems in Safety Systems of Nuclear Power Generating Stations

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ANSI/UL 1998 (Complete Document)

Revision / Edition: 3    Chg:     Date: 12/18/13   Abbreviations Definitions

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Software in Programmable Components, Second Edition

Published By: UL (UL)

Page Count: 38

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ISO BSI

BS ISO 26262-6 (Complete Document)

Revision / Edition: 1ST    Chg:     Date: 11/15/11   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 2.0    Chg:     Date: 05/00/06   Abbreviations Definitions

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Software for Computers in the Safety Systems of Nuclear Power Stations

Published By: International Electrotechnical Commission (IEC)

Page Count: 226

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IEC BSI

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Revision / Edition: 2.2    Chg:     Date: 08/00/13   Abbreviations Definitions

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Published By: International Electrotechnical Commission (IEC)

Page Count: 649

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IEC BSI

IEC 61508-1 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 04/00/10   Abbreviations Definitions

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Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements

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Page Count: 132

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IEC BSI

IEC 61508-2 (Complete Document)

Revision / Edition: 2.2    Chg:     Date: 04/00/10   Abbreviations Definitions

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Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems -

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Published By: International Electrotechnical Commission (IEC)

Page Count: 192

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IEC BSI

IEC 61508-3 (Complete Document)

Revision / Edition: 2.2    Chg:     Date: 04/00/10   Abbreviations Definitions

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Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems

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Published By: International Electrotechnical Commission (IEC)

Page Count: 236

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IEC BSI

IEC 61508-5 (Complete Document)

Revision / Edition: 2.0    Chg:     Date: 04/00/10   Abbreviations Definitions

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Functional Safety of Electrical/Eelectronic/Programmable Eelectronic Safety-Related Systems

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Published By: International Electrotechnical Commission (IEC)

Page Count: 102

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IEC BSI

IEC 61508-6 (Complete Document)

Revision / Edition: 2.2    Chg:     Date: 04/00/10   Abbreviations Definitions

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Functional safety of electrical/ electronic/ programmable electronic safety-related systems. Guidelines on the application of IEC 61508-2 and IEC 61508-3

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Page Count: 240

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IEC BSI

IEC 62304 (Complete Document)

Revision / Edition: 1.0    Chg:     Date: 05/00/06   Abbreviations Definitions

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Medical device software - Software life cycle processes

Published By: International Electrotechnical Commission (IEC)

Page Count: 164

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IEEE BSI

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Revision / Edition: 94    Chg:     Date: 12/10/02   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 1ST    Chg:     Date: 11/15/11   Abbreviations Definitions

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ISO BSI

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Revision / Edition: 1ST    Chg:     Date: 11/01/13   Abbreviations Definitions

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Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary

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BSI BSI

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Revision / Edition: 13    Chg:     Date: 10/31/14   Abbreviations Definitions

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(SEPT Checklist Available in MS Word Format)

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Page Count: 94

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MIL-STD BSI

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Revision / Edition: E    Chg:     Date: 05/11/12    Abbreviations Definitions

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RTCA BSI

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Revision / Edition: C    Chg:     Date: 12/13/11   Abbreviations Definitions

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SAE BSI

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Revision / Edition: A    Chg: W/ STBL     Date: 07/00/13   Abbreviations Definitions

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BSI BSI

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Revision / Edition: 11    Chg:     Date: 04/30/14   Abbreviations Definitions

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Software Security Standards
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IEC BSI

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Revision / Edition: 95    Chg: W/ REAP     Date: 00/00/13   Abbreviations Definitions

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Page Count: 17

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IEC BSI

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Revision / Edition: 2ND    Chg:     Date: 06/15/07   Abbreviations Definitions

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IEC BSI

ISO/IEC 9797-1 (Complete Document)

Revision / Edition: 2ND    Chg:     Date: 03/01/07   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 2ND    Chg:     Date: 05/01/11   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 3rd    Chg:     Date: 07/01/10   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 2ND    Chg: COR2    Date: 07/15/12   Abbreviations Definitions

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IEC BSI

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Revision / Edition: 3rd    Chg: COR    Date: 03/15/08   Abbreviations Definitions

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IEC BSI

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