SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF DISINFECTANT FLUID, PHENOLIC TYPE ACCORDING TO IS 1061:1997 (With Amendment No.

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1 SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF DISINFECTANT FLUID, PHENOLIC TYPE ACCORDING TO IS 1061:1997 (With Amendment No.1) 1.0 LABORATORY: A laboratory shall be maintained which shall be suitably equipped and staffed where different tests given in the specification shall be carried out in accordance with the method given in the Table All testing apparatus shall be periodically checked and calibrated and records of such checks/calibration shall be maintained. 2.0 TEST RECORDS: All records of tests and inspection shall be kept in suitable forms approved by the Bureau. 2.1 Copies of any record and other connected papers that may be required by the Bureau shall be made available at any time on request. 3.0 QUALITY CONTROL: It is recommended that as far as possible, statistical Quality Control (SQC) methods may be used for controlling the quality during production as envisaged in the scheme see IS 397 (Part 1):1972, IS 397 (Part 2):1975 and IS 397 (Part 3): In addition efforts shall be made to gradually introduce the Quality Management System as per IS/ISO 9001 as appropriate to the activities of the organization. 5.0 STANDARD MARK: The Standard Mark as given in column (1) of the First Schedule of the license shall be stenciled on each container of Disinfectant Fluids, Phenolic type or printed on the label applied to the container as the case may be, provided always that the material in the container to which this Mark is thus applied conforms to every requirement of the specification. In case of 25 litres tins the Standard Mark may also be incorporated in the lead seal. 6.0 MARKETING: In addition, the following information shall be given on each container or printed on the label applied to it: a) Name of the product; b) Manufacturer s name, initials or trade mark;

2 c) Class, Grade and type of the material and phenol coefficient (Rideal Walker or Rideal walker and staphylococcal); d) Batch number/control Unit; e) Month and year of manufacture; f) Net volume in ml or l; g) Any specific instructions for use; h) A statement that mercury compounds have not been added to the product; i) Date of expiry; j) Any other marking required under the Weights and Measure (Packaged Commodities) Rules and Drugs and Cosmetic Rules, 1956; and k) CM/L PACKING: The material shall be packed as per Cl.5 of IS 1061: CONTROL UNIT: For the purpose of this scheme, the entire quantity of disinfectant fluids, phenolic type homogenized at a time in one tank shall be considered as a Control Unit. 9.0 LEVELS OF CONTROL: The tests, as indicated in table 1 and at the levels of control specified therein, shall be carried out on the whole production of the factory covered by this Scheme and appropriate records and charts maintained in accordance with Paragraph 2 above. All the production which conform to the Indian Standard and covered by this license shall be marked with the Standard Mark. 9.1 A sample of the material shall be drawn from each C.U. and tested for all the requirements of the specification except for stability on storage. If the sample fails in any of the requirements, the batch shall be rejected. The rejected material could however, be reprocessed and the defects rectified. Such reprocessed material when tested again shall confirm to all the requirements of the specification for the relevant grade before it is used for making. 9.2 The sample of each type shall be kept for stability on storage every month and shall be tested just before the expiry period declared by the manufacturer. If it fails, a thorough check shall be made of the process of manufacture, as also of the raw materials used in the manufacture of the materials. 9.3 Mercury compounds shall be strictly excluded from all grades of disinfectant fluids.

3 10.0 In respect of all other clauses of the specification and at all stages of production appropriate controls and checks shall be maintained by the factory so as to ensure that the product conforms to the various requirements of the specification. 11. RAW MATERIALS: It is recommended that routine analysis of various raw materials used in the manufacture of disinfectant fluid shall be made on each lot received in the factory and appropriate records to be maintained REJECTION: A separate record shall be maintained giving information relating to the rejection of the production not conforming to the requirements of the specification and the method of its disposal. Such material in no case be stored together with those conforming to the requirements of the specification SAMPLE: The licensee shall supply, free of charge, the samples required in accordance with the Bureau of Indian Standard (Certification) regulations, 1988 as subsequently amended from his factory or godown. The Bureau shall pay for the samples taken by it from the open market REPLACEMENT: Whenever a complaint is received soon after the goods with Standard Marks have been purchased and used and if there is adequate evidence that the goods have not been misused, defective goods are replaced free of cost by the licensee in case the complaint is proved to be genuine and the warranty period (when applicable) has not expired. The final authority to judge the conformity of the product to the Indian Standard shall be with the Bureau In the event of any damages caused by the goods bearing the standard Mark or claim being filed by the consumers against BIS Standard Mark and not conforming to the relevant Indian standard, entire liability arising out of such non-conforming product shall be of licensee and BIS shall not in any way be responsible in such cases STOP MARKING: The marking of the product shall be stopped under intimation to the Bureau if, at any time, there is some difficulty in maintaining the conformity of the product to the specification, or the testing equipment goes out of order. the marking may be resumed as soon as the defects are removed under intimation to BIS.

4 15.1 The marking of the product shall be stopped immediately if directed to do so by BIS for any reason. The marking may then be resumed only after permission by BIS. The information regarding resumption of markings shall also be sent to the Bureau PRODUCTION DATA: The licensee shall send to the Bureau as per the enclosed Proforma, to be authenticated by a Chartered accountant a statement of quantity produced, marked and exported by them and the trade value thereof at the end of each operative year of the license.

5 IS 1061: 1997 DISINFECTANT FLUIDS, BLACK AND WHITE TABLE 1 LEVELS OF CONTROL (Clause of Scheme of Testing and Inspection) Clause Requirements TEST DETAILS Test Method LEVELS OF CONTROL No. of Frequency Samples Remarks Clause Reference 4.1 Composition and Description or IS 1061:1997 One Each Control Unit. 4.2 Stability after dilution Annex-A -do- One -do- 4.3 Germicidal Value Annex-B & C -do- One -do- 4.4 Mercury Compound Annex-D -do- One Once in a month. 4.5 Stability on storage 4.2,4.3 & 4.5 -do- One Once in month