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PM Is-12254 Cmd-2 Final

This document is a product manual for Polyvinyl Chloride (PVC) Industrial Boots according to IS 12254:2021, outlining guidelines for certification under the Bureau of Indian Standards. It includes details on sampling, testing equipment, inspection schemes, and licensing scope for various designs and protection levels of the boots. The manual serves as a reference for regional offices and applicants seeking BIS certification, ensuring compliance and transparency in the certification process.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
4 views14 pages

PM Is-12254 Cmd-2 Final

This document is a product manual for Polyvinyl Chloride (PVC) Industrial Boots according to IS 12254:2021, outlining guidelines for certification under the Bureau of Indian Standards. It includes details on sampling, testing equipment, inspection schemes, and licensing scope for various designs and protection levels of the boots. The manual serves as a reference for regional offices and applicants seeking BIS certification, ensuring compliance and transparency in the certification process.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 14

PM/ 12254/ 2

December 2022

www.bis.gov.in

उत्पाद मैनअ
ु ल
पॉलीविनाइल क्लोराइड (पी िी सी ) औद्योगिक जूते
12254 : 2021 के अनस
ु ार

PRODUCT MANUAL FOR


POLYVINYL CHLORIDE (PVC) INDUSTRIAL BOOTS
ACCORDING TO IS 12254 : 2021

ु पता मूलयाांकन) विननयम 2018 की स्कीम-I के तहत यह उत्पाद मैनअ


भारतीय मानक ब्यूरो (अनरू ु ल प्रमाणीकरण
ु ांगता और पारदर्शिता सनु नश्चचत करने के र्लए सभी क्षेत्रीय/शाखा कायािलयों एिां लाइसेन्स
की सांचालन रीनत में सस
धाररयों द्िारा सांदभि सामग्री के रूप मे उपयोग ककया जाएगा। बीआईएस लाइसेन्स/प्रमाण पत्र प्राप्त करने के इच्छुक
भािी आिेदकों द्िारा भी इस दस्तािेज़ का उपयोग ककया जा सकता है।

This Product Manual shall be used as reference material by all Regional/Branch Offices & licensees
to ensure coherence of practice and transparency in operation of certification under Scheme-I of
Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 for various products. The
document may also be used by prospective applicants desirous of obtaining BIS certification
licence/certificate.

1. उत्पाद :
IS 12254 : 2021
Product
शीर्षक : पॉलीविनाइल क्लोराइड (पी िी सी ) औद्योगिक ज ूते
Title POLYVINYL CHLORIDE (PVC) INDUSTRIAL BOOTS
संशोधन संख्या : 0
No. of Amendments Nil
2. नमन
ु ाकरण ददशा ननदे श
Sampling Guidelines:
Toe caps (Cl. 5.4.6), Penetration resistance insert (Cl.
कच्चा माल 5.4.8.3.1), Upper (Cl. 5.5), Lining (5.6), Insole (5.7), Press
a) : buttons, Eyelets and Laces (Cl 5.8), Insocks (Cl. 5.9), Closing
Raw material thread (Cl. 5.10) and Outsole (Cl. 5.11) shall conform to the
requirements of respective clauses of IS 12254.
b) समदू िकरण ददशा ननदे श : कृपया Annex-A देखें
PM/ 12254/ 2
December 2022
Grouping guidelines Please see Annex – A
c) नमूनेका पररमाण : 5 pairs of shoes of each variety (In case samples are sent to a
Sample Size different lab for testing innocuousness of materials, 2 pairs are
required to be sent separately)
3. परीक्षण उपकरणो की सूची : कृपया Annex-B दे खें
List of Test Equipment Please see Annex – B
ननरीक्षण ि परीक्षण स्कीम कृपया Annex-C दे खें
4. Scheme of Inspection : Please see Annex – C
and Testing
5. एक ददन में संभावित Size, Height of upper, Internal length of toecap, Impact
resistance, Compression resistance, Colour, Upper Thickness,
परीक्षण
Insole thickness, Insocks thickness, Eyelet size, Laces length,
Possible tests in a day : Outsole thickness, Lead content.

6. लाइसेन्स का कायषक्षेत्र /Scope of the Licence:


IS 12254 : 2021 के अनस
ु ार मानक मिु र का उपयोग करने के ललए लाइसेन्स ननम्नललखित कायषक्षत्र

के ललए प्रदान ककया जाता िै
Licence is granted to use Standard Mark as per 12254 : 2021 with the following scope:
Name of the product Polyvinyl Chloride (PVC) Industrial boots
Design Type I – Ankle boots
and/or Type II – Wellington/gum boots
Protection Level Variety 1 – For use as safety footwear (with metallic/ non-metallic
toecaps) and/or
Variety 2 – For use as protective footwear (with metallic/ non-
metallic toecaps) and/or
Variety 3 – For use as occupational footwear
Size From 4 to 12 (English size) for adults (as applicable)
Additional Requirements Without Additional Requirements, or
With Additional Requirements (As applicable as follows)
Whole Footwear Conductive Footwear
Antistatic Footwear
Penetration resistance
Cut resistance
Resistance to acid and alkali
Resistance to fuel oil
Upper Cold Flex Resistance
Outsole Cold Flex Resistance

BUREAU OF INDIAN STANDARDS


ManakBhawan, 9, Bahadur Shah ZafarMarg,
New Delhi – 110002
PM/ 12254/ 2
December 2022

ANNEX – A
TO THE PRODUCT MANUAL FOR
POLYVINYL CHLORIDE (PVC) INDUSTRIAL BOOTS AS PER IS 12254 : 2021
GROUPING GUIDELINES

1. Polyvinyl Chloride (PVC) Industrial Boots have Been classified in following designs, protection level
and sizes:
i) Design :
Type I- Ankle Boots [Design B of IS 15298 (Part 2)],
Type-II- Wellington/gum boots [Design D of IS 15298 (Part 2)].
ii) Protection level :
Variety 1 – For use as safety footwear,
Variety 2 – For use as protective footwear,
Variety 3 – For use as occupational footwear.
iii) Sizes : 4 to 12 (English Size)

2. For considering grant of licence/inclusion of varieties, one sample of each Design (Type I / Type II) and
each Protection level (Variety 1/ Variety 2/ Variety 3) of any size shall be drawn and tested to cover
that design, Protection level and all the sizes being manufactured.

3. Additional Requirements shall be indicated in the scope of licence only if the sample has been tested
for those Additional requirements.

4. However, while considering grant of licence/inclusion of additional sizes/designs/varieties, it will be


ensured that the applicant/licensee has got the complete manufacturing and testing facilities for all the
sizes, designs and varieties intended to be covered.

5. During operation of the licence, BO will ensure that all the sizes/designs/varieties covered in the license
are tested in Rotation. The above guidelines may be followed for grant of license as well as inclusion of
new variety.
PM/ 12254/ 2
December 2022

ANNEX –B
TO THE PRODUCT MANUAL FOR
POLYVINYL CHLORIDE (PVC) INDUSTRIAL BOOTS AS PER IS 12254 : 2021
LIST OF TEST EQUIPMENTS

Major test equipment required to test as per the Indian Standard

Sr. Tests used in with Clause Test equipment


No. Reference
1. Size, 5.2 Measuring Tape
Steel Scale
2. Height of Upper, 5.3
Digital Vernier Caliper
Ergonomic feature, 5.4.2 Stairs (17 + 3)
3. Stop watch
Tensile Testing Machine with flat jaws with 100±20 mm/min speed
Upper-Outsole bond Strength, as per Cl.5.2.2 of IS-15298 (part-1)
4.
5.4.3 Steel Scale
Knife
5. Slip resistance, 5.4.4 Test Machine and material as per Cl. 5.11.2.2 of IS 15298 (Part 1)
Water bath,
6. Leakproofness, 5.4.5
Supply of compressed air
Toe Caps –
Steel scale,
General, 5.4.6.1
7. Thickness gauge,
Internal Length of toecap,
Appropriate gauge to measure the internal length,
5.4.6.2
1 % aqueous solution of sodium chloride
8. Corrosion Resistance , 5.4.6.3 Dish with a glass plate,
Filter paper
Impact apparatus as per cl. 5.4.1 of IS 15298 (Part 1),
9. Impact Resistance, 5.4.6.4
Clamping device, Cylinders, Dial gauge,
Compression Resistance, Compression testing machine as per cl. 5.5.1 of IS 15298 (Part 1)
10. 5.4.6.5 Clamping device, Cylinders, Dial gauge,
Electrical Resistance
(Conductive footwear, 5.4.8.1 Surface Resistivity Meter as per clause 5.10.2 IS 15298(Part 1)
11.
& Antistatic Footwear, 5.4.8.2 Steel Balls of diameter 5 mm, Weight 4 kg
)
Penetration Resistance, Penetration Resistance Test Apparatus as per cl. 5.8.2.1 of IS 15298
12.
5.4.8.3.2 (Part 1), Test nail
Apparatus for testing cut resistance (Coupe test equipment) as per cl.
13. Cut Resistance, 5.4.8.4
6.2.2 of EN 388
Sulphuric acid,
Resistance to acid and alkali,
14. Hydrochloric acid
5.4.8.5
Sodium Hydroxide
PM/ 12254/ 2
December 2022
Tensile Testing Machine with speed provision of 100 mm per
minute, Dumb bell die with cutter
Durometer, Type A, hardness tester as per cl. 2.1 of IS 12240 (Part 2)
Weighing balance
Conditioning Chamber
Beaker
15. Resistance to Fuel Oil, 5.4.8.6 Press Knife
Shore A Hardness Tester
2, 2, 4 Trimethyl pentane, general purpose Reagent
16. Thickness of upper, 5.5.1 Thickness gauge as per cl. 6.1 of IS 15298 (Part 1)
Tensile strength, 5.5.2 Tensile Testing Machine with speed provision of 100 mm per
17.
minute, Dumb bell die with cutter
18. Flexing Resistance, 5.5.3 Apparatus for determination of resistance to flexing
Durometer, Type A, hardness tester as per cl. 2.1 of IS 12240 (Part
19. Hardness, 5.5.4
2)
Cold Flex resistance for Apparatus for determination of resistance to flexing,
20.
upper, 5.5.5 Refrigerated cabinet
Tensile Testing Machine in accordance with cl. 6.3 of IS 15298 (Part
1)
21. Tear strength of lining, 5.6.2 Press Knife
Steel Scale
Conditioning Chamber
Abrasion Machine as per cl. 6.12.2 of IS 15298 (part 1)
Reference Abradant Pad
Backing
Fabric Punch or press cutter
Weight
Specimen Holder
Abrading Base
Abrasion Resistance of lining,
22. Balance
5.6.3
Conditioning Chamber
Dial Gauge
Filler Gauge
Woven felt
Hygrometer
Air conditioner
Thermometer
Adhesion of Lining with Testing machine as per IS 3400 (Part 5)
23.
Upper Cutting tool
24. Insole Thickness, 5.7.1 Graduated eyepiece with 0.1 mm scale graduations
Abasion Tester as per cl. 7.3.2 of IS15298 (Part 1)
Wool pads
Abrasion resistance of Insole,
25. Abradant fabric
5.7.2
Conditioning Chamber
Distilled Water
PM/ 12254/ 2
December 2022
Water Absorption & Desorption Tester as per 7.2.2 of IS 15298
(Part 1)
Brass Roller
Platform
Clamp (D) and clamp (E) as per IS 15298 (Part 1)
Water Absorption and
26. Cotton gauge
Desorption, 5.7.3
Water Supply through flow meter
Press Knife
Balance
Clock
Silicone grease
Tensile Testing Machine as per Cl. 6.1 of IS 1969 (Part 1) Or IS
1969 (Part 2)
Cutter for cutting test specimens
27. Eyelets and laces, 5.8
Grade 3 water as per IS 1070
Non ionic wetting agent
Beaker/ or any suitable container for immersion of sample
28. Insocks Thickness, 5.9 Dial Thickness gauge
Abrasion Machine as per cl. 6.12.2 of IS 15298 (Part 1)
Reference Abradant Pad
Backing
Fabric Punch
Weight
Specimen Holder
Abrading Base
Insocks Abrasion resistance,
29. Balance
5.9.2
Conditioning Chamber
Dial Gauge
Filler Gauge
Woven felt
Hygrometer
Air conditioner
Thermometer
Water Absorption & Desorption Tester as per 7.2.2 of IS 15298
(Part 1)
Brass Roller
Platform
Clamp (D) and clamp (E) as per IS 15298 (Part 1)
Insocks water absorption and
30. Cotton gauge
Desorption, 5.9.3
Water Supply through flow meter
Press Knife
Balance
Clock
Silicone grease
Tensile Testing Machine & Drying oven as per Cl. 5 of IS 4910
31. Closing Thread, 5.10
(Part 3)
PM/ 12254/ 2
December 2022
32. Thickness of outsole, 5.11.1 Dial Thickness gauge
Balance
Balance Straddle
33. Outsole density, 5.11.2 Beaker
Copper Wire
Conditioning Chamber
Tensile Testing Machine as per cl.5.2.2 of IS 15298 (Part 1)
Interlayer Bond
34. Steel Scale
Strength,5.11.3
Knife
Tensile Testing Machine as per cl. 8.2 of IS 15298 (Part 1)
35. Tear Strength, 5.11.4
Press Knife
Abrasion Testing Machine as per cl. 8.3 of IS 15298 (Part 1)
Conditioning Chamber
Analytical Balance
36. Abrasion Resistance, 5.11.5
Cutting Die
Weight
Abrasion Sheet
37. Sole Hardness, 5.11.6 Durometer, Type A, hardness tester as per cl. 2.1 of IS 12240 (Part 2)
Flexing Testing Machine as per fig. 45 of IS 15298 (Part 1)
38. Flexing Resistance, 5.11.7 Cutting Tool (as per ISO 5423)
Magnifier
Outsole cold flex resistance, Flexing machine (Satra Ross Type), Refrigerated cabinet (-5±2°C),
39.
5.11.8 Piercing chisel,
A suitable oven with constant air circulation and capable of
40. Volatility, 6.1 maintaining temperature at 135 ± 5 ̊C
Desiccator
Nessler Cylinder – 50 ml Capacity
p-Nitrophenol Indicator solution
Dilute Ammonium Hydroxide
Dilute Hydrochloric Acid
Hydrogen Sulphide Solution
Standard Lead solution
41. Lead Content, 6.2
Lead Nitrate
Distilled Water
Volumetric Flasks
Pipette
Weighing balance
Whatman filter paper No. 41 or its equivalent.
Chemical requirements as per
42. As per IS 17011
table 1 of IS 17011
Conditioning Chamber
43. Other equipments Blower for temperature maintenance
Air conditioner
The above list is indicative only and may not be treated as exhaustive.
PM/ 12254/ 2
December 2022

ANNEX C
TO THE PRODUCT MANUAL FOR
POLYVINYL CHLORIDE (PVC) INDUSTRIAL BOOTS
AS PER IS 12254 : 2021
Scheme of Inspection And Testing

1. LABORATORY - A laboratory shall be maintained which shall be suitably equipped (as per the
requirement given in column 2 of Table 1) and staffed, where different tests given in the specification shall
be carried out in accordance with the methods given in the specification.

1.1 The manufacturer shall prepare and implement a calibration plan for the test equipments.

2. TEST RECORDS – The manufacturer shall maintain test records for the tests carried out to establish
conformity.

3. PACKING AND MARKING – The Standard Mark, as given in the Schedule of the licence, shall be
stamped on the underside of each pair of PVC boot, provided always that the product so marked conform
to requirements of the specification.

3.1 Packing and marking shall be done as per the provisions of IS 12254 : 2021. In addition, the following
details shall be mentioned on each container/package:-

a) BIS Licence No. CM/L--------.


b) BIS website details i.e. –“For details of BIS certification please visit www.bis.gov.in”.

4. CONTROL UNIT – Finished PVC Industrial Boots of one type and variety produced in a day from the
same consignment of raw material shall constitute a control unit.

5. LEVELS OF CONTROL - The tests as indicated in column 1 of Table 1 and the levels of control in
column 3 of Table 1, shall be carried out on the whole production of the factory which is covered by this
plan and appropriate records maintained in accordance with paragraph 2 above.

5.1 All the production which conforms to the Indian Standards and covered by the licence should be marked
with Standard Mark.

6. REJECTIONS – Disposal of non-conforming product shall be done in such a way so as to ensure that
there is no violation of provisions of BIS Act, 2016.
PM/ 12254/ 2
December 2022

TABLE 1 (Levels of Control)


(Para 5 of Scheme of Inspection and Testing)

(1) (2) (3)


Test Details Test equipment Levels of Control
Clause Requirement Test Method requirement No. of Frequency Remarks
Clause Reference R: Required (or) Samples
S: Sub-contracting
permitted
5.2 Size 5.2 IS 12254 R 5 Each control unit All sizes & varieties
being manufactured
shall be tested in
rotation.
5.3 Height of 6.2 IS 15298 (Part 1) R 5 Each control unit -do-
upper
5.4 Properties of Whole Footwear
5.4.1 Construction 5.4.1 IS 12254 All
R -
5.4.2 Ergonomic 5.1 IS 15298(Part 1) 1 Every 7th control All sizes & varieties
feature R unit being manufactured
shall be tested in
rotation.

5.4.3 Upper outsole 5.2 IS 15298(Part 1) 1 Every 7th control -do-


Bond strength R unit

5.4.4 Slip Resistance 5.11 IS 15298(Part 1) S 1 Once in a month -do-

5.4.5 Leakproofness 5.7 IS 15298(Part 1) R 1 Every 7th control -do-


unit

5.4.6 Toe Caps ( Applicable for variety 1 and variety 2 )

5.4.6.1 General 5.4.6.1 IS 12254 R All


PM/ 12254/ 2
December 2022

5.4.6.2 Internal length 5.3 IS 15298 (Part 1) R/S* As per Each Consignment *No testing is required if
of toecap Sampling material is ISI marked or
5.4.6.3 Corrosion Annex IS 5852 (Part 1) R/S* plan given in accompanied with
resistance E Annex – F of manufacturer’s test
(Applicable for IS 5852 certificate indicating
metallic (Part 1) : conformity to the
toecaps) 2019 requirement.

5.4.6.4 Impact 5.4 IS 15298 (Part 1) R 1 Every 7th control All sizes & varieties
Resistance unit being manufactured
shall be tested in
rotation.

5.4.6.5 Compression 5.5 IS 15298 (Part 1) R 1 Every 7th control -do-


Resistance unit
5.4.7 Colour 5.4.7 IS 12254 R All

5.4.8 Additional requirements for whole footwear (If required by purchaser)

5.4.8.1 Conductive 5.10 IS 15298 (Part 1) R 1 Once in a month All sizes & varieties
footwear being manufactured
shall be tested in
rotation.
5.4.8.2 Antistatic 5.10 IS 15298 (Part 1) R 1 Once in a month -do-
footwear
5.4.8.3.1 Penetration IS 17275 (Part 1) S 1 Each Consignment No testing is required if
resistance or material is ISI marked
insert IS 17275 (Part 2) or accompanied with
manufacturer’s test
certificate indicating
conformity to the
requirement.
5.4.8.3.2 Penetration 5.8.2 IS 15298 (Part 1) R 1 Every 7th control All sizes & varieties
Resistance unit being manufactured
shall be tested in
rotation.
PM/ 12254/ 2
December 2022

5.4.8.4.1, Cut Resistance IS 12254 R 1 Every 7th control All sizes & varieties
5.4.8.4.2, IS 12254 unit being manufactured
5.4.8.4.3 6.14 IS 15298 (Part 1) shall be tested in
rotation.
5.4.8.5 Resistance to Annex IS 12254 R 1 Every 7th control -do-
acid and alkali B unit
5.4.8.6 Resistance to 8.6.1 IS 15298 (Part 1) R 1 Every 7th control -do-
fuel oil unit
5.5 Upper

5.5.1 Material 5.5.1 IS 12254 R All

5.5.1 Thickness 6.1 IS 15298 (Part 1) R 5 Each control unit All sizes & varieties
being manufactured
shall be tested in
rotation.
5.5.2 Tensile 6.4 IS 15298 (Part 1) R 1 Every 7th control -do-
Strength unit
5.5.3 Flexing 6.5 IS 15298 (Part 1) R 1 Every 7th control -do-
Resistance unit
5.5.4 Hardness IS 12240 (Part 2) R 1 Every 7th control -do-
unit
5.5.5 Additional – Annex ISO 4643 S 1 Once in a month -do-
Cold Flex B
Resistance (If
required by
purchaser)
5.6 Lining (Variety 1 and 2 shall have lining)

5.6.1 Lining 5.6.1 IS 12254 R All


Material
5.6.2 Tear Strength 6.3 IS 15298 (Part 1) R 1 Every 7th control All sizes & varieties
unit being manufactured
shall be tested in
rotation.
5.6.3 Abrasion 6.12 IS 15298(Part 1) R 1 Every 7th control -do-
resistance unit
PM/ 12254/ 2
December 2022

5.6.4 Adhesion of IS 3400 (Part 5) R 1 Every 7th control All sizes & varieties
lining with unit being manufactured
Upper shall be tested in
rotation.
5.7 Insole
5.7.1 Material & 5.7.1 IS 12254 R 5 Each control unit -do-
thickness
5.7.2 Abrasion 7.3 IS 15298 (Part 1) R 1 Every 7th control -do-
resistance unit
5.7.3 Water 7.2 IS 15298 (Part 1) R 1 Every 7th control -do-
absorption and unit
desorption
5.8 Press Buttons, Eyelets and Laces (Applicable for Type 1 Boots)

5.8.1 Press Buttons 5.8.1 IS 12254 R All

5.8.2 Eyelets and 5.8.2 IS 12254 R 1 Each control unit


laces – Material
and size
5.8.2 Breaking load IS 1969(Part 1) S 1 Each Consignment No testing is required if
of laces Or IS 1969 (Part 2) material is ISI marked
or accompanied with
manufacturer’s test
certificate indicating
conformity to the
requirement.
5.9 Insocks
5.9 Thickness 5.9 IS 12254 R 5 Each control unit All sizes & varieties
being manufactured
shall be tested in
rotation.
5.9.1 Material 5.9.1 IS 12254 R All

5.9.2 Abrasion 6.12 IS 15298 (Part 1) R 1 Every 7th control All sizes & varieties
resistance unit being manufactured
shall be tested in
rotation.
PM/ 12254/ 2
December 2022

5.9.3 Water 7.2 IS 15298 (Part 1) R 1 Every 7th control All sizes & varieties
absorption and unit being manufactured
desorption shall be tested in
rotation
5.10 Closing IS 4910 (Part 3) S 1 Each Consignment No testing is required if
thread material is ISI marked
(If used) or accompanied with
manufacturer’s test
certificate indicating
conformity to the
requirement.
5.11 Outsole

5.11.1 Material 5.11.1 IS 12254 R All

5.11.1 Thickness 5.11.1 IS 12254 R 5 Each control unit All sizes & varieties
being manufactured
shall be tested in
rotation.
5.11.2 Outsole IS 12240 (Part 3) R 1 Every 7th control -do-
density unit
5.11.3 Interlayer 5.2 IS 15298 (Part 1) R 1 Every 7th control -do-
Bond Strength unit
5.11.4 Tear Strength 8.2 IS 15298 (Part 1) R 1 Every 7th control -do-
unit
5.11.5 Abrasion 8.3 IS 15298 (Part 1) R 1 Every 7th control -do-
resistance unit
5.11.6 Sole hardness IS 12240 (Part 2) R 1 Every 7th control -do-
unit
5.11.7 Flexing 8.4 IS 15298 (Part 1) R 1 Every 7th control -do-
Resistance unit
5.11.8 Additional – Annex ISO 4643 S 1 Once in a month -do-
Cold Flex -C
Resistance (If
required by
purchaser)
PM/ 12254/ 2
December 2022

6 Chemical Requirements
6.1 Volatility IS 12240 (Part 4) R 1 Every 7th control All sizes & varieties
unit being manufactured
shall be tested in
rotation.
6.2 Lead Content IS 12240 (Part 5) R 1 Every 7th control -do-
unit
6.3 Requirements IS 17011 S 1 Once in a six At least once every six
as per table 1 months months or whenever
of IS 17011 there is any change in
source of raw material.

Note 1: Whether test equipment is required or sub-contracting is permitted in column 2 shall be decided by the Bureau and shall be
mandatory. Sub-contracting is permitted to a laboratory recognized by the Bureau or Government laboratories empanelled by the Bureau.

Note 2: Levels of control given in column 3 are only recommendatory in nature. The manufacturer may define the control unit/batch/lot
and submit his own levels of control in column 3 with proper justification for approval by BO Head.

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