|
Medical
Device Standards |
Name |
To order a standard from
Techstreet, Click on order. |
|
ANSI/AAMI HE74-2001 |
Human Factors
Design Process for Medical Devices
|
Order |
|
ANSI/AAMI/ISO 13485:2003 |
Medical Devices - Quality Management
Systems - Requirements for Regulatory Purposes
(Checklist Available)
|
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|
|
ANSI/AAMI/ISO 14971 |
Risk Management - Part 1: Application of Risk
Management
to
Medical Devices |
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|
|
ANSI/UL 1998 |
Software in Programmable Components, Second Edition
(Checklist
Available)
(Free Power Point Presentation on how to implement
this standard. See detail at the bottom of this page) |
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|
|
ASTM E 1578 |
Standard Guide for
Laboratory Information Management System |
Order |
|
FDA
Guidance Document 2 |
Guidance
for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use
in Medical Devices.
(Checklist Available) |
Order |
|
FDA
Guidance Document 3 |
Guidance
for the Content of Pre-market Submissions for Software
Contained in Medical Devices.
(Checklist Available) |
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|
|
FDA Guidance Document
4 |
General Principles of
Software Validation - Final Guidance for Industry and FDA
Staff
(Checklist
Available)
|
Order |
|
FDA 21 CFR
Part 11 |
Electronic Records;
Electronic Signatures; Final Rule-FDA
, 21CFR Part 11
(Checklist
Available) |
Order |
| IEC 60601-1-1
|
Medical Electrical
Equipment-Part 1: General Requirements for Safety- Collateral Standard:
Safety Requirements for Medical Electrical Systems |
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| IEC 60601-1-4 |
Medical Electrical
Equipment--Part 1: General Requirements for Safety-4. Collateral Standard: Programmable
Electrical Medical Systems
(Checklist Available) |
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|
| IEC 61508-3 |
Functional Safety of
Eelectrical/Eelectronic/Programmable
Eelectronic Safety-Related
Systems - Part 3: Software Requirements |
Order |
|
IEC 62304 |
Medical device software - Software life cycle processes
(Checklist Available)
|
Order |
|
ISO 9001:2000 |
Quality
Management Systems - Requirements
(Checklist Available)
|
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|
|
ISO/IEC 12207:2008 |
Systems and software engineering-Software
life cycle
processes |
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|
| ISO/IEC 15288:2008 |
Systems and software engineering-System
life cycle
processes (Discounted
Combo Set of 12207 and 15288 (save 5%) |
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|
|
ISO/IEC 27002:2005 |
Information Technology
- Code of Practice for Information
Security Management
(Checklist Available) |
Order |
| ISO/IEC
90003 |
Software
Engineering. Guidelines for the
Application of ISO
9001:2000 to Computer Software
(Checklist Available)
|
Order
|
