Clinical Evaluation

Assessment and analysis of clinical data concerning a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer

Labeling

Label, instructions to be used, and the other information that's associated with identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents

Medical Device Family

Group of medical devices manufactured by or for an equivalent organization and having an equivalent basic design and performance characteristics associated with safety, intended use and performance.

Sterile Barrier System

Minimum package that forestalls ingress of microorganisms and allows aseptic presentation of the merchandise at the purpose of use.

Sterile Medical Device

Medical device intended to satisfy the wants for sterility

Medical Device File

For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.

Work Environment

The organization shall document the wants for the work environment needed to realize conformity to product requirements.

If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the wants for the work environment and therefore the procedures to watch & control the work environment.

Contamination Control

As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product so as to stop contamination of the work environment, personnel or product.

For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate and maintain the specified cleanliness during assembly or packaging processes.

Planning of Product Realization

Plan and develop the processes needed for product realization. Planning of product realization shall be according to the wants of the opposite processes of the standard management system.

Design & Development

Plan and control the planning and development of product. As appropriate, design and development planning documents shall be maintained and updated because the design and development progresses.

Cleanliness of Product

Document requirements for cleanliness of product or contamination control of product if:

a) Product is cleaned by the organization before sterilization or its use;

b) Product is supplied non-sterile and is to be subjected to a cleaning process before sterilization or its use;

c) Product can't be cleaned before sterilization or its use, and its cleanliness is of significance in use;

d) Product is supplied to be used non-sterile, and its cleanliness is of significance in use;

e) Process agents are to be far away from product during manufacture