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MDRQ #1730

MDRQ #1690: ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

MDRQ #1718: CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTURE

10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices.

Added by Anonymous over 6 years ago.

Status:
Released
Priority:
Low

Description

10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices.


Subissues

MDRQ #1731: Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.ReleasedActions

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