BS EN 12442-1:2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
English
15-11-2000
29-02-2008
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Superseded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 |
| Standards | Relationship |
| NBN EN 12442-1 : 2000 | Identical |
| EN 12442-1 : 2000 | Identical |
| NS EN 12442-1 : 1ED 2000 | Identical |
| NEN EN 12442-1 : 2000 | Identical |
| NF EN 12442-1 : 2000 | Identical |
| I.S. EN 12442-1:2000 | Identical |
| DIN EN 12442-1:1998-05 (Draft) | Identical |
| DIN EN 12442-1:2001-01 | Identical |
| UNE-EN 12442-1:2001 | Identical |
| 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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