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AAMI ST72 : 2011 : R2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
Available format(s)

Hardcopy , PDF

Superseded date

25-11-2019

Language(s)

English

Published date

01-01-2016

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality management system elements
5 Non-pyrogenic labeling
6 Selection of product units
7 Selection of technique
8 Validation of methodology
9 Use of technique
10 Alternatives to batch testing
Annex A - Background on the bacterial endotoxins test
Annex B - Guidance on test methods, routine monitoring, and
          alternatives to batch testing
Annex C - Guidance on out of specification (OOS) and failure
          investigation
Annex D - Bibliography

Describes general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods.

Committee
WG 08
DocumentType
Standard
Pages
51
ProductNote
Reconfirmed 2016
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
ASTM D 7102 : 2017 : REDLINE Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

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