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BS EN 12442-1:2000

BS EN 12442-1:2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk

Available format(s)

Hardcopy , PDF

Superseded date

29-02-2008

Superseded by

BS EN ISO 22442-1:2007
BS EN ISO 22442-1:2015

Language(s)

English

Published date

15-11-2000

Publisher

British Standards Institution

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Hardcopy - English
PDF - English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedure
5 Requirements for risk management
6 Review of risk analysis
ANNEX A (informative) Graphical representation of the risk
                      management process
ANNEX B (informative) Guidance on the application of this
                      Part of EN 12442
ANNEX C (informative) Applicability of relevant information
                      annexes in EN 1441
ANNEX D (informative) Transmissible agents risk analysis
                      and management
ANNEX ZA (informative) Clauses of this standard addressing
                       Essential Requirements or other
                       provisions of EU Directives
Bibliography

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).

Committee
CH/194
DevelopmentNote
Supersedes 96/562030 DC (03/2002)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
S.R. CEN ISO TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)

EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN 30993-4 : 1993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
EN 30993-3 : 1993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY
EN 1174-1 : 1996 STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
EN 30993-6 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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