CMD-II (Legal)

CMD-II/16:16289 18 March 2015

Subject : Tentative STI and Grouping Guidelines for IS 16289 for comments

All India first application for MEDICAL TEXTILES – SURGICAL FACE MASKS, as per IS
16289:2014, was recorded by MUBO(EEE). The tentative STI and Grouping
Guidelines approved by DDGW are enclosed for reference and comments. TXD, MSD
and all ROs, BOs are requested to examine the same for comments. In case no
comments are received within 30 days the tentative STI and Grouping Guidelines
shall be processed for finalization.

(P.S.Yadav)
Sc-E
Circulated to all ROs, BOs
 Doc:STI/16289
February 2015

SCHEME OF TESTING AND INSPECTION

FOR CERTIFICATION OF
MEDICAL TEXTILES – SURGICAL FACE MASKS
ACCORDING TO IS 16289:2014

1.0 Laboratory – A laboratory shall be maintained which shall be suitably equipped

and staffed where the tests shall be carried out in accordance with the methods
given in the specification.

2.0 Test Records – All records of tests shall be kept in suitable forms approved
by the Bureau of Indian Standards.

2.1 Copies of any records or charts that may be required by 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 this Scheme [See IS 397 (Part I) : 2003, IS 397 (Part
II):2003, IS 397 (Part III) : 2003 and IS 397 Part IV) : 2003].

3.1 In addition efforts should be made to gradually introduce a Quality

Management System in accordance with the quality system modules as per IS / ISO
9001.

4.0 Standard Mark – The Standard Mark (s), as given in Column (I) of the First
Schedule of the licence, shall be suitably marked on each Surgical Face mask and
its container, provided always that the Surgical face mask to which this mark is thus
applied, conform to every requirement of the specification.

4.1 Marking – In addition, the following information shall be clearly and indelibly
marked on Surgical face mask:
(i) For Face Mask:

(a) The name, trade mark or other means of identification of the manufacture;
(b) Class 1, Class 2 or Class 3

(ii) For Package:

(a) The name, trade mark or other means of identification of the
manufacturer;
(b) Class 1, Class 2 or Class 3.
(c) The month and year of manufacture; and
(d) Any other statutory requirements as required by the Law in force.
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February 2015

4.2 Every consignment of Surgical Face masks shall be supplied with the following:

a) A certificate to the effect that the units being supplied have been tested as per the
requirements of the specification and found suitable for use.

5.0 Levels of Control – The analysis and 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 which is
covered by this Scheme and appropriate records and charts maintained in accordance with
paragraph 2 above. All the production, which conforms to the Indian Standard and covered by
the licnece shall be marked with Standard mark of the Bureau.

5.1 For the purpose of this scheme, all Surgical face masks of one class produced in a day
shall be constitute a control unit .

5.2 Surgical face masks shall be tested at levels of control specified in Table 1. In case of failure
in Bacterial filtration efficiency, the twice the no. of samples be tested for that requirement. If a
further failure occurs, the entire lot shall not be marked.

5.3 In respect of all other clauses of the specification and at all stages of production, the factory
shall maintain appropriate controls and checks to ensure that their product conforms to various
requirements of the specification.

6.0 Rejections – A separate record shall be maintained giving information relating to the
rejection of control units of material which do not conform to the specification and the method of
their disposal. Such material, if packed in containers, shall in no case be stored together with
that conforming to the specification.

7.0 Samples - The licensee shall supply, free of charge the sample or samples required in
accordance with the Bureau of Indian Standards (Certification) Regulations, 1988 as
subsequently amended, from time to time, from his factory or godown. Bureau shall pay for the
samples taken by it from the open market.

8.0 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 or their components are to be replaced or repaired free of cost by the
licensee in case the complaint is proved to be genuine and the warranty period (where
applicable) has not expired. The final authority to judge the conformity of the product to the
Indian Standard shall be with the Bureau. The firm should have own complaint Investigation
system as per IS 15400.

8.1 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 responsible in such cases.
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February 2015

9.0 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 their 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.

10.0 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.

11.0 Production Data- - The licensee shall send to BIS, as per the enclosed proforma, a
statement of the quantity produced, marked and exported by him and the trade value thereof
during the half year ending 30 June and 31 December. This statement is required to be
forwarded to BIS on or before the 31st day of July and January for the proceeding half-year.
 DOC:STI/10629
February 2014

MEDICAL TEXTILES – SURGICAL FACE MASKS

ACCORDING TO IS 16289:2014
TABLE 1 LEVELS OF CONTROL
(Para 5 of the Scheme of Testing and Inspection)

Test Details Levels of control

Clause Requirement Test Methods No. of Frequency Remarks
Clause Reference Samples

4.2 Bacterial Filtration Table 1 IS 16288 5 (A.T.C *) Each 15th Also please
Efficiency control unit see clause
5.2 of the
scheme
-do- Differential Table 1 & IS 16289 5 (A.R**) Each control -
Pressure Annex C unit

-do- Splash Resistance Table 1 & IS 16289 5 (A.T.C*) Each control -

Annex D unit

-do- Sub-micron Table 1 & IS 16289 5 (A.T.C*) Each control -

particulate filtration Annex E unit
efficiency at 0.1 µ

* A.T.C – After Temperature Conditioning

** A.R - As received