BS ISO 8009 pdf download Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
This International Standard specifies the minimum requirements and test methods to be used forreusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended forcontraceptive use.
This International Standard is not applicable to other vaginal contraceptive barriers, such as thoseknown as cervical caps, vaginal sponges, and vaginal sheaths.
2 Normative references
The following documents,in whole or in part,are normatively referenced in this document and areindispensable for its application, For dated references, only the edition cited applies. For undatedreferences, the latest edition of the referenced document (including any amendments) applies.
SO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
SO 463, Geometrical Product Specifications (GPS) – Dimensional measuring equipment — Design andmetrological characteristics ofmechanical dial gauges
SO 2859-1:1999,Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed byacceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a riskmanagementprocess
ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
3 Terms and definitions
For the purpose ofthis document, the terms and definitions given in ISO 2859-1 and the following apply
collection of diaphragms of the same design, colour, shape, size, and formulation, manufactured atessentially the same time, using the same process, common lots of raw materials, common equipmentand personnel
Note 1 to entry: The size ofalot is not specified in this International Standard,but it can be specified by a purchaseras part of a purchasing contract, Depending on the method of manufacture, multiple sizes can be produced in adefined lot/batch.In such cases, traceability can be maintained by using both the lot number and the size
Sampling and establishment of the sampling plan shall be carried out as described in ISO 2859-1.
NOTE It is necessary to know the lot size in order to derive from ISO 2859-1 the number of samples to be tested. The lot size varies among manufacturers, and is regarded as part of the process and quality controls used by the manufacturer.
Diaphragms shall be classified into the following types:
a) Type 1: Coil-spring diaphragm, also known as a helically wound diaphragm.
b) Type 2: Flat-spring diaphragm, also known as a flat-leaf diaphragm, watch-spring diaphragm, or Mensinga diaphragm.
c) Type 3: Arcing-spring diaphragm, also known as an arcing-bend diaphragm or bow-bend diaphragm.
The diaphragm, excluding the spring, shall be made of a natural or silicone rubber compound.