ISO 8009-2014 pdf free download

ISO 8009-2014 pdf free download.Mechanical contraceptives — Reusable natural and silicone
rubber contraceptive diaphragms — Requirements and tests
Contruceptifs mécan iq ues — Diaph ragmes cvii trace ptifs réu tulsa bles en caoutchouc — Performances et essais.
10 Mechanical properties of rim and spring — Type 1 and Type 2 diaphragms
10.1 Compression resistance
When 13 diaphragms are tested In accordance with Annex E. during the first and 1 000th compressions the distance between the load points, i.e. resulting from compression, of each diaphragm shall not be lower than 55 % and not greater than 85 % of the original diameter.
After the 1 000th compression, the diameter along the axis of compression shall be at least 90 % of the value measured before the test.
After the 1 000th compression, the rubber film shall show no signs of deterioration when examined by normal or corrected vision.
The degree of twist after 1 000 compressions, measured in accordance with AnnexE shall be not more than 200.
Manufacturers of diaphragms who are certified to the Iso 9001 quality management system or equivalent, and whose suppliers are similarly certified, may use the repeated compression testing part of this method as a type test. In that case, lot-by-lot testing shall consist of a single compression, and measurement of the compression resistance.
10.2 Twisting during compression
When tested in accordance with Annex F. the diaphragm shall not show an angle of twist greater than
20°.
Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least according to code letter K.
When tested in accordance with AnnexE the compliance level shall be an AQL of 1,0 %.
11 Freedom from visible defects
When inspected in accordance with AnnexL the diaphragm shall not show any visible defects.
Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least according to code letter K.
The compliance level shall be an AQL of 0,4 % for the following major defects:
a) hole in the dome;
b) exposed spring;ISO 8009-2014 pdf free download.