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BS EN 46001:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Specification for application of EN ISO 9001 to the manufacture of medical devices

Available format(s)

Hardcopy , PDF

Superseded date

15-03-2001

Language(s)

English

Published date

15-02-1997

€165.94
Excluding VAT

Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality system requirements
   4.1 Management responsibility
   4.2 Quality system
   4.3 Contract review
   4.4 Design control
   4.5 Document and data control
   4.6 Purchasing
   4.7 Control of customer-supplied product
   4.8 Product identification and traceability
   4.9 Process control
   4.10 Inspection and testing
   4.11 Control of inspection, measuring and test equipment
   4.12 Inspection and test status
   4.13 Control of nonconforming product
   4.14 Corrective and preventive action
   4.15 Handling, storage, packaging, preservation and delivery
   4.16 Control of quality records
   4.17 Internal quality audits
   4.18 Training
   4.19 Servicing
   4.20 Statistical techniques
Annex A (informative) - Bibliography

Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.

Committee
CH/210/1
DevelopmentNote
Supersedes 90/56565 DC. To be read in conjunction with EN ISO 9001. (07/2003)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
DIN EN 46001:1996-09 Identical
UNE-EN 46001:1996 Identical
NBN EN 46001 : 1996 Identical
NEN EN 46001 : 1996 Identical
EN 46001 : 1996 Identical
I.S. EN 46001:1997 Identical
SN EN 46001 : 1997 Identical
NF EN 46001 : 1996 Identical

BS EN 724:1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
BS EN 1174-1:1996 Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements
BS 2574-2:1994 Lower limb orthoses Specification for hip, knee and ankle joints for lower limb orthoses
BS EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
BS EN 928:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization

BS EN ISO 9001:2015 Quality management systems. Requirements
EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 50103 : 1995 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
EN 928 : 1995 IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
BS EN ISO 8402:1995 Quality management and quality assurance. Vocabulary

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