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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002
Hardcopy , PDF
12-01-2003
English
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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Superseded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 |
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