BS EN 46001:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Specification for application of EN ISO 9001 to the manufacture of medical devices
Hardcopy , PDF
15-03-2001
English
15-02-1997
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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Superseded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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