ANSI AAMI ISO 13488:1996 pdf download – Quality systems – Medical devices – Particular requirements for the application of ISO 9002
1 Scope
This International Standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.
This International Standard, in conjunction with ISO 9002, is applicable when there is a need to assess a medical device supplier’ s quality system.
As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this International Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
NOTE-In this Intermational Standard the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the supplier can document a justification otherwise. A requirement is considered “appropriate” if its non-implementation could result in
-the product not meeting its specified requirements, and/or
– the supplier being unable to carry out crrective action.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
ISO 8402:1994, Quality management and quality assurance-Vocabulary.
ISO 9002:1994, Quality systems-Model for quality assurance in production, installation and servicing.
ISO 11137:1995, Sterilization of healthcare products- Requirements for validation and routine contro-Radiation sterilization.
3 Definitions
For the purposes of this International Standard, the definitions given in ISO 8402 apply, with the exception that the definition of “product” as given in ISO 9002 applies. In addition, the followving definitions apply.
NOTE-These definitins should be regarded as generic, as definitins provided in national regulations may dftr sligtly.
3.1 medical device: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of
-diagnosis, prevention, monitoring, treatment or alleviation of disease,
-diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap,
-investigation, replacement or modification of the anatomy or of a physialogical process,
-control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted in its function by such means.
NOTE-In addition to the medical device categories defined hereinafter, the term “medical device” also includes nonactive medical devices and in vitro diagnostic devices.