• There are no items in your cart

CSA ISO 13488 : 1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ISO 9002
Available format(s)

Hardcopy , PDF

Superseded date

12-01-2003

Language(s)

English

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

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

DocumentType
Standard
Pages
21
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

Standards Relationship
ISO 13488:1996 Identical

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

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

View more information
US$55.00
Excluding Tax where applicable

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, flexible and cost effective.