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BS EN 12442-2:2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
Available format(s)

Hardcopy , PDF

Superseded date

02-29-2008

Language(s)

English

Published date

11-15-2000

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Sourcing; general; species and strain
6 Sourcing of animal materials: Inspection,
      certification and traceability
7 Collection
8 Handling
9 Storage and transport
10 Derivatives and other specialized cases
Annex A (normative) Additional requirements relating to
                    the application of EN 12442-2 to
                    bovine sourced materials
Annex B (informative) Certification and attestation
Annex C (informative) Veterinary services
Annex ZA (informative) Clauses of this European Standard
                       addressing Essential Requirements
                       or other provisions of EC Directives
Bibliography

Defines requirements for controls on sourcing, collection and handling of animals and tissues (including storage and transport) of animals and tissues for manufacture of medical devices using materials of animal origin other than in vitro diagnostic medical devices.

Committee
CH/194
DevelopmentNote
Supersedes 96/562031 DC (03/2002)
DocumentType
Standard
Pages
20
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Superseded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
CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
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 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK

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