TS EN ISO 13488
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
This standard covers the particular requirements for the application of ISO 9002 to medical devices.
Available Formats:
- Availability: Immediate Download
- Language: English
- License Type: Single User
- Updates: Not Included
- Availability: Request Quote
- Language: English
- License Type: Enterprise / Multi User
- Updates: Included
About This Item
TS EN ISO 13488 addresses the particular requirements for applying EN ISO 9002 to medical devices. In practical terms, it adapts the general quality system model to a product sector where controlled manufacturing, documentation, and consistency are especially important.
How the quality system concept fits medical devices
Medical devices are typically developed and produced through linked processes such as manufacturing, assembly, sterilization, packaging, distribution, and traceability control. A quality system standard does not define the device itself; instead, it organises how the relevant processes are controlled so the product remains consistent and fit for its intended purpose. EN ISO 9002 is the process-oriented base referenced here, and TS EN ISO 13488 places that model in the medical-device context.
What this document covers
- Particular requirements for the application of ISO 9002 to medical devices.
- Quality management and quality assurance terminology and expectations relevant to medical equipment contexts.
- The referenced source is EN ISO 13488:2000, and this record is marked withdrawn.
- It is a quality-system standard rather than a product specification for one specific device type.
- Publication Date: 25.04.2002
- Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)
- Publisher: TSE
- Document Language: tr, en, fr, de
- ICS Classification: 03.120.10 Kalite Yönetimi ve Kalite Güvencesi; 11.040.01 Tıbbi Ekipman (Genel)
- Pages: 10
- Source Standard: EN ISO 13488:2000
- International Equivalents: ISO 13488--; EN ISO 13488--; NF S99-102--; DIN EN ISO 13488--
Need This Standard?
Request a personalized quote today to receive the latest edition in PDF or other available formats.
Need This Standard?
Request a personalized quote today to receive the latest edition in PDF or other available formats.
Summarize with AI
Get quick summaries using your favorite AI engine.
Online Standart Disclaimer
OnlineStandart.com is an authorized reseller of international standards, operating through partnerships with authorized distributors. We do not own the copyrights or trademarks of the standards we sell, including but not limited to those of API, ASHRAE, BSI, SAE, ASTM, IEEE, IEC, ASME, ISO, and others.
All product names, logos, and brands are the property of their respective owners and are used for identification purposes only; their use does not imply endorsement. OnlineStandart.com is not affiliated with or endorsed by any standards development organization unless explicitly stated. The content of this document is for informational purposes only and is intended to promote our licensed reselling services.
Online Standart does not host, distribute, or link to free, unlicensed, or uncertified copies of copyrighted standards. Every document we deliver is a licensed copy obtained through authorized channels and supplied with full licensing documentation. The “Free PDF Download” option on our product pages refers to this free informational document — never to a free copy of any standard.