The Standards (Declaration of Compulsory Standards) Notice, 2024

This Notice may be cited by its short title and starts operating 60 days after publication.

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Jurisdiction: Tanzania
Instrument: Notice
Citation: The Standards (Declaration of Compulsory Standards) Notice, 2024
Version: Undated source snapshot
Language: en
Official source: View official record ↗

commencement commodity regulation compliance medical devices product compliance standards surgical implants technical standards

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This Notice may be cited by its short title and starts operating 60 days after publication. The Standards listed in the Schedule are declared compulsory for each commodity listed there. This section lists several standards that are compulsory. This provision appears to list standard references and related TZS amounts, but the text is fragmented. This section identifies a compulsory standards notice for implants for surgery made of metallic materials.

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Provisions of The Standards (Declaration of Compulsory Standards) Notice, 2024

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1
This Notice may be cited as the Standards
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AI-assisted research summary: This Notice may be cited by its short title and starts operating 60 days after publication.

1. This Notice may be cited as the Standards (Declaration of Compulsory Standards) Notice, 2024 and shall come into operation sixty days from the date of its publication. Declaration of Compulsory Standards
2
The Standards specified in the Schedule to
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AI-assisted research summary: The Standards listed in the Schedule are declared compulsory for each commodity listed there.

2. The Standards specified in the Schedule to this Notice are hereby declared to be Compulsory Standards for each commodity specified thereunder. ____________ SCHEDULE _____________ (Made under paragraph 2) S/N Standard Number Title of the Commodity Category

Part

SCHEDULE

3
Section 3
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AI-assisted research summary: This section lists several standards that are compulsory.

3. TZS 3291- 1:2022/IEC 60831- 1:2014 Artificial pollution tests on high-voltage ceramic and glass insulators to be used on a.c. systems Surge arresters - Part 8: Metal-oxide surge arresters with external series gap (EGLA) for overhead transmission and distribution lines of a.c. systems above 1 kV Shunt power capacitors of the self-healing type for a.c. systems having a rated voltage up to and including 1 000 V - Part 1: Compulsory Compulsory Compulsory 1 Standards (Declaration of Compulsory Standards) Notice GN. No. 190 (Contd) S/N Standard Number Title of the Commodity Category test self-healing General - Performance, testing and rating - Safety requirements - Guide for installation and operation Shunt power capacitors of the self-healing type for a.c. systems having a rated voltage up to and including 1 000 V - Part 2: Ageing and test, destruction test Electricity metering equipment - General requirements, tests and test conditions - Part 11: Metering equipment Electricity metering equipment - Particular requirements - Part 21: Static meters for AC active energy (classes 0,5, 1 and 2) High-voltage switchgear and control gear - Part 111: Automatic circuit reclosers for to and alternating current systems up including 38 kV Borosilicate glass 3.3 - Properties. Laboratory glassware - Pipettes - Colour coding. Laboratory glass and plastics ware - Principles of design and construction of volumetric instruments. glassware Laboratory conical ground joints. Laboratory glassware - Graduated pipettes. -Interchangeable Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Laboratory glassware – Beakers. Compulsory - Single-volume Laboratory glassware pipettes Laboratory glassware -Graduated measuring cylinders. Implants for surgery - Metallic materials - Part 1: Wrought stainless steel. Compulsory Compulsory Compulsory Implants for surgery -Metallic materials - Part 2: Unalloyed titanium. Compulsory

Part

Part 2: Unalloyed titanium.

7
Section 7
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AI-assisted research summary: This provision appears to list standard references and related TZS amounts, but the text is fragmented.

7. 11:2022/IEC 62052- 11:2020 TZS 1628- 21:2022/IEC 62053- 21:2020 TZS 3284- 111:2022/IEC 62271-111:2019
18
TZS 3309
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AI-assisted research summary: This section identifies a compulsory standards notice for implants for surgery made of metallic materials.

18. TZS 3309- Implants for surgery-Metallic materials-part Compulsory 2 Standards (Declaration of Compulsory Standards) Notice GN. No. 190 (Contd) S/N Standard Number Title of the Commodity Category 3:2022/ISO 5832- 3:2021
32
TZS 3315:2022/ISO
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AI-assisted research summary: This section lists multiple medical and related standards as compulsory.

32. TZS 3315:2022/ISO 14630:2012 3: Wrought Titanium 6-Aluminium 4- Vanadium alloy Implants for surgery-Metallic materials-Part 4: Cobalt-Chromium Molybdenum casting alloy Implants for surgery-Metallic materials-Part 5: Wrought Cobalt-Chromium-Tungsten- Nickel alloy Implants for surgery-Metallic materials-Part 6: Wrought Cobalt-Nickel-Chromium- Molybdenum alloy Implants for surgery-Metallic materials-Part 7: Forgeable and cold-formed Cobalt- Chromium-Nickel-Molybdenum-Iron alloy. Implants for surgery-Metallic materials-Part 9: Wrought high nitrogen stainless steel Implants for surgery-Metallic materials-Part 11: Wrought Titanium 6-Aluminium 7- Niobium alloy Implants for surgery-Metallic materials-Part 12: Wrought-Cobalt-Chromium- Molybdenum alloy Implants for surgery-Metallic materials-Part 14: Wrought Titanium 15-Molybdenum 5- Zirconium 3-Aluminium alloy Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems Metallic materials-Tensile testing-Part 1: Method of test at room temperature of risk Medical devices-Application management to medical devices Cardiovascular artificial and implants organs-Cardiopulmonary bypass systems- Arterial blood line filters. Clinical investigation of medical devices for human subjects - Good clinical practice Non-active surgical requirements implants-General 3 Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Standards (Declaration of Compulsory Standards) Notice GN. No. 190 (Contd) S/N Standard Number Title of the Commodity Category
42
TZS 3323:2022/ISO
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AI-assisted research summary: This section lists several standards and specifications as compulsory.

42. TZS 3323:2022/ISO 2919:2012 - (Class L) industrial oils and industrial oils and industrial oils and industrial oils and Lubricants, related products (class L) - Machine-tool lubricants - Categories and specifications related Lubricants, products (class L) -Family E (internal combustion engine oils) -Specifications for oils for use in four-stroke cycle motorcycle gasoline engines and associated drivetrains (categories EMA and EMB) related Lubricants, products Family D (compressors) - Part 1: Specifications of categories DAA and DAB (lubricants for reciprocating and drip feed rotary air compressors) related Lubricants, (Class L) — Family D products (compressors) — Part 3: Specifications of categories DRA, DRB, DRC, DRD, DRE, DRF and DRG (lubricants for refrigerating compressors) Lubricants, related products (class L) -Classification - Part 3: Family D (Compressors) Geotechnical investigation and testing - Identification and classification of soil - Part 2: Principles for a classification Decentralized wastewater treatment systems - General the environment Fecal sludge management - Permissible limits for use and disposal Radionuclide gauges - Gauges designed for permanent installation. Radiological Protection -Sealed radioactive sources and classification. industrial oils and requirements tolerance -General limits to Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Compulsory Dodoma, 11th March, 2024 ASHATU K. KIJAJI Minister for Industries and Trade 4

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