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ANSI AAMI ISO 13488 pdf free download

ANSI AAMI ISO 13488 pdf free download.Quality systems- -Medical devices- – – Particular requirements for the application of ISO 9002.
4.8 Product identification and traceability
The requirements given in 4.8 of ISO 9002:1 994 apply.
Particular requirement for all medical devices:
a) Identification
The supplier shall establish and maintain procedures to ensure that medical devices returned to the supplier for reprocessing to specified requirements are identified and distinguished at all times from normal production (see 4.15.1).
b) Traceability
The supplier shall establish, document and maintain procedures for traceability. The procedures shall define the extent of traceability and shall facilitate corrective and preventive action (see 4.14).
Additional requirements for active implantable medical devices and implantable medical devices:
When defining the extent of traceability, the supplier shall include all components and materials used and records of the environmental conditions [see 4.9 b)4)] when these could cause the medical device not to satisfy its specified requirements.
The supplier shall require that its agents or distributors maintain records of the distribution of medical devices with regard to traceability and that such records are available for inspection.
4.9 Process control
The requirements given in 4.9 of ISO 9002:1 994 apply.
Particular requirements for all medical devices:
a) Personnel
The supplier shall establish, document and maintain requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or environment could adversely affect the quality of the product.
The supplier shall ensure that all personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained person (see 4.18).
b) Environmental control in manufacture
For medical devices
1) that are supplied sterile, or
2) that are supplied non-sterile and intended for sterilization before use, or
3) if the microbiological and/or particulate cleanliness or other environmental conditions are of significance in their use, or
4) if the environmental conditions are of significance in their manufacture, the supplier shall establish and document requirements for the environment to which product is exposed.
If appropriate, the environmental conditions shall be controlled and/or monitored.
c) Cleanliness of product
The supplier shall establish, document and maintain requirements for the cleanliness of product if
1) product is cleaned by the supplier prior to sterilization and/or its use, or
2) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
3) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
4) process agents are to be removed from product during manufacture.
If appropriate, product cleaned in accordance with 1) or 2) above need not be subject to the preceding particular requirements [i.e. a) Personnel, and b) Environmental control in manufacture] prior to the cleaning procedure.d) Maintenance
The supplier shall establish and document requirements for maintenance activities when such activities may affect product quality.
Records of such maintenance shall be kept (see 4.16).
e) Installation
If appropriate, the supplier shall establish and document both instructions and acceptance criteria for installing and checking the medical device.
Records of installation and checking performed by the supplier or its authorized representative shall be retained (see 4.16).
If the contract (see 4.3) allows installation other than by the supplier or its authorized representative, the supplier shall provide the purchaser with written instructions for installation and checking.
f) Computer software used in process control
The supplier shall establish and maintain documented procedures for the validation of the application of computer software which is used for process control. The results of validation shall be recorded (see 4.16).
Additional requirement for sterile medical devices:
The supplier shall subject the medical device to a validated sterilization process and record (see 4.16) all the control parameters of the sterilization process.ANSI AAMI ISO 13488 pdf download.

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