• CSA ISO 13488 : 1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ISO 9002

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-12-2003

    Language(s):  English

    Published date: 

    Publisher:  Canadian Standards Association

    Add To Cart

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

    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

    Abstract - (Show below) - (Hide below)

    Defines the quality system requirements for the production and, when relevant, installation and servicing of medical devices.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Superseded
    Superseded By

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

    CSA ISO 7207-1 : 0 IMPLANTS FOR SURGERY - FERMORAL AND TIBIAL COMPONENTS FOR PARTIAL AND TOTAL KNEE JOINT PROSTHESES - PART 1: CLASSIFICATION, DEFINITIONS AND DESIGNATION OF DIMENSIONS
    CSA ISO 8319-1 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 1: KEYS FOR USE WITH SCREWS WITH HEXAGON SOCKET HEADS
    CSA ISO 8319-2 : 0 ORTHOPAEDIC INSTRUMENTS - DRIVE CONNECTIONS - PART 2: SCREWDRIVERS FOR SINGLE SLOT HEAD SCREWS, SCREWS WITH CRUCIATE SLOT AND CROSS-RECESSED HEAD SCREWS
    CSA ISO 5833 : 0 IMPLANTS FOR SURGERY - ACRYLIC RESIN CEMENTS
    CSA ISO 5835 : 0 IMPLANTS FOR SURGERY - METAL BONE SCREWS WITH HEXAGONAL DRIVE CONNECTION, SPHERICAL UNDER-SURFACE OF HEAD, ASYMMETRICAL THREAD-DIMENSIONS
    CSA ISO 5832-2 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM
    CSA ISO 5832-4 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY
    CSA ISO 5832-3 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANDIUM ALLOY
    CSA ISO 5832-5 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 5: WROUGHT COBALT-CHROMIUM-TUNGSTEN-NICKEL ALLOY
    CSA ISO 7206-2 : 0 IMPLANTS FOR SURGERY - PARTIAL AND TOTAL HIP JOINT PROSTHESES - PART 2: ARTICULATING SURFACES MADE OF METALLIC, CERAMIC AND PLASTICS MATERIALS
    CSA ISO 5832-6 : 0 IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 6: WROUGHT COBALT-NICKEL-CHROMIUM-MOLYBDENUM ALLOY

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

    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective