Common use of APPLICABLE QUALITY CONTROL STANDARDS Clause in Contracts

APPLICABLE QUALITY CONTROL STANDARDS. The product will be manufactured in accordance with the quality practices specified in the following documents: o EN 46001:1996, Quality Systems — Medical Devices — Particular Requirements for the Application of EN29001 o ISO 13485:1996, Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001 o Quality System Regulations specified in the Current Good Manufacturing Practices (CGMP) for medical devices; 21 CFR part 820

APPLICABLE QUALITY CONTROL STANDARDS. The product will be manufactured in accordance with the quality practices specified in the following documents: o • EN 46001:1996, 46001:1996 Quality Systems — Medical Devices — Particular Requirements for the Application of EN29001 o • ISO 13485:1996, Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001 o • Quality System Regulations specified in the Current Good Manufacturing Practices (CGMP) for medical devices; 21 CFR part 820

APPLICABLE QUALITY CONTROL STANDARDS. The product will be manufactured in accordance with the quality practices specified in the following documents: o • EN 46001:1996, Quality Systems — Medical Devices — Particular Requirements for the Application of EN29001 o • ISO 13485:1996, Quality Systems — Medical Devices — Particular Requirements for the Application of ISO 9001 o • Quality System Regulations specified in the Current Good Manufacturing Practices (CGMP) for medical devices; 21 CFR part 820