TS EN 46001
Quality Systems-Medical Devices-Particular Requirements For The Application Of EN 29001
This standard specifies, in can junction with EN 29001 the quality system requirements for the production and where relevent installation of medical devices.
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- Language: English
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About This Item
TS EN 46001 is a sector-specific quality system standard for medical devices, intended to be used together with EN 29001 for the production and, where appropriate, installation of medical devices. It links the general discipline of quality management to the tighter process control, traceability, and product assurance needs typical of medical technology.
How the medical-device quality system context fits together
In general technical terms, medical devices require controlled design, manufacturing, inspection, storage, and in some cases installation. A quality system in this field is therefore about more than end-product checking: it relies on planned processes, documented responsibilities, records, and the handling of nonconformities. EN 29001 provides the broad quality-system framework, while TS EN 46001 adapts that framework to the particular conditions associated with producing and installing medical devices.
What this document covers in practice
- Its focus is the production of medical devices, and where relevant their installation.
- It applies the general quality-system requirements with medical-device-specific expectations in mind.
- It is defined for use in conjunction with EN 29001, rather than as a standalone generic quality standard.
- This listing is withdrawn and is historically linked to EN 46001:1993 and AC:1994.
- Publication Date: 29.03.1996
- Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)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: 17
- Source Standard: EN 46001:1993+AC:1994
- International Equivalents: EN 46001 (1993) EQV* 46001 AC (1994), EQV--; DIN EN 46001--; EN 46001:1993* EN 46001 AC:1994--
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