BS ISO 20308:2016 pdf free
BS ISO 20308:2016 pdf free.Traditional Chinese medicine – Gua Sha instruments
BS ISO 20308 specifies the product classification, requirements of appearance, cleaning and disinfection, hardness, roughness, resistance to abrasion, magnetic field, biocompatibility, size of Gua Sha instruments, as well as related information on package, transport and storage, labelling and instructions for use.
Electro-devices and other forms are excluded in this standard.
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1:2009, Biological evaluation of medical devices一Part 1: Evaluation and testing within a risk management process
ISO 10993-10, Biological evaluation of medical devices一Part 10: Tests for irritation and skin sensitization
ISO 10993-18, Biological evaluation of medical devices一Part 18: Chemical characterization of materials
ISO/TS 10993-19, Biological evaluation of medical devices一Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/IEC Guide 37, Instructions for use of products of consumer interest
The internal exposure indexof Gua Sha instrument shall be no more than 0.5, and external exposure index shall be no more than 0.65.
The biocompatibility of the Gua Sha instrument shall be assessed and documented according to the guidance and principles given in ISO 10993-1.
Compliance is demonstrated by:
a) analogy with published data; or
b) the selection of materials already shown to be biocompatible by proven clinical use in a similar application; or
c) experience with similar devices already on the market together with evidence of traceability to the materials used in the Gua Sha instrument; or
d) compliance with published procedures for biological evaluation of medical devices.
The Gua Sha instrument shall be sealed in a primary package. There shall be no foreign matter within the primary package under visual inspection.
The material and design of this primary package shall not have detrimental effects on the contents. The material and design of this primary package should be such as to ensure:
a) the maintenance of the contents under dry, clean and adequately ventilated storage conditions;
b) the minimum risk of contamination of the contents during removal from the package;
c) adequate protection of the contents during normal handling, transit and storage; and
d) that once opened, the package cannot be easily resealed, and it shall be obvious that the package has been opened. BS ISO 20308 pdf free.
