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Standards for other mechanical contraceptive - Standards for ‘Copper T’ and ‘Tubal Ring’ shall be as laid down in Annexure VI. 1[ANNEXURE I [See Paragraph 4-A] Sampling Plan for Quality Control of Condoms at Manufacturer’s Level. BATCH SIZE: 35,001 TO 1.5 LAKH. Single Sampling Plan Sample Size 200: AQL - 0.25 AC - 1 R - 2 _______________________________________________________________________ 1 Subs. by. G.S.R. 353(E) , for “ Annexures I to III” dt. 26-4-2000. Drugs and Cosmetics Rules, 1945 474 BATCH SIZE: 150001 TO 5 LAKHS Single Sampling Plan Sample Size 315 : AQL - 0.25 AC - 2 R - 3 BATCH SIZE: OVER 5 LAKHS Single Sampling Plan. Sample Size 500: AQL - 0.25 AC - 3 R - 4 Note : AQL denotes Acceptance Quality Level; AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch. ANNEDURE II [See Paragraph 5A] Sampling Plan for Quality Control of Condoms at Purchaser’s Level. BATCH SIZE: 35,001 TO 1.5 LAKHS Single Sampling Plan Sample Size 200: AQL - 0.25 AC - 1 R - 2 BATCH SIZE : 15,001 TO 5 LAKHS Single Sampling Plan. Sample Size 315: AQL - 0.25 AC - 2 R - 3 BATCH SIZE : OVER 5 LAKHS Single Sampling Plan Sample Size 500: AQL - 0.25 AC - 3 R - 4 Note: AQL denotes Acceptance Quality Level; AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch. Drugs and Cosmetics Rules, 1945 475 ANNEXURE III [See Paragraph 4-B and 5-B] Sampling Plan for Bursting Volume and Pressure Test. BATCH SIZE: 35,001 TO 1.5 LAKH. Single Sampling Plan. Sample Size 200: AQL - 1.5 AC - 7 R - 8 BATCH SIZE: 150001 LAKHS TO 5 LAKHS Single Sampling Plan. Sample Size 315: AQL - 1.5 AC - 10 R - 11 BATCH SIZE: OVER 5 LAKHS Single Sampling Plan. Sample Size 500: AQL - 1.5 AC - 14 R - 15 Note : AQL denotes Acceptance Quality Level; AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch.] ANNEXURE IV (See Paragraph 9) Determination of Bursting Volume and Pressure