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DIN EN 46001:1996-09

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
Available format(s)

Hardcopy , PDF

Superseded date

01-02-2001

Language(s)

English

Published date

01-01-1996

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.

DocumentType
Standard
Pages
16
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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

DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES

DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)

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