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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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    Superseded date:  15-03-2001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

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Committee CH/210/1
    Development Note Supersedes 90/56565 DC. To be read in conjunction with EN ISO 9001. (07/2003)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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