Appoint a Service Provider to Undertake Quality Assurance Services for Covid-19 Personal Protective Equipment (PPE) on Behalf of Department of Health

• Country: South Africa
• Summary: Appoint a Service Provider to Undertake Quality Assurance Services for Covid-19 Personal Protective Equipment (PPE) on Behalf of Department of Health
• ZAT Ref No: 60619760
• Deadline: 21 Dec 2021
• Financier: Other Funding Agencies
• Purchaser Ownership: Government
• Tender Value: Refer Document
• Notice Type: Tender
• Document Ref. No.:
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• Description:
• Request for proposals are invited for Appoint a Service Provider to Undertake Quality Assurance Services for Covid-19 Personal Protective Equipment (Ppe) on Behalf of Department of Health for a Period of Three Months Tender Number ‘isi2021 Quality Assurance Services for Ppe. Respirators (n95) Small, Medium, Large Sans 50149, Respiratory Protective Devices- Filters Half Masks to Protect against Particles- Requirements, Testing, Marking Sans 1866, Part 2: Medical Respirators Sans 10220, Standard for Selection, Use and Maintenance of Respiratory Ppe (Guidance Standard not Tested against) Sahpra: Class B *Minimum ffp2 According to en 149, Eu Ppe. * Regulation 2016/425 Category Iii, or * Minimum n95 Respirator According to Fda Class Ii, under 21 Cfr 878.4040. And Cdc Niosh, or Equivalent Iso 16900-1 Iso 17420-1 and 2 Iso/Ts 16976-8: 2013, Respiratory Protective Devices- Human Factors- Part 8: Ergonomic Factors 42 Cfr Part 84 Chinese Paho Standards According to en 149 Respiratory Protective Devices- 2 Surgical Mask One Size Sans 1866-1 2018 Medical Devices Part 1: Medical Face Masks Sans 1866 : 2008 (Provides Alternative Tests to the, Bfe Test) Sans 50149: 2003 Sahpra Class a Non- Sterile- Exclusion from Shpra Licence *Eu Mdd Directive 93/42/Eec Category Iii or Equivalent *en 14683 Type Ii, Ir, Iiir *Astm f2100 Minimum Level 1 or Equivalent Iso/ Ts 16976-8:2013, Respiratory Protective Devices- Human Factors-Part 8: Ergonomic Factors. Chinese Paho Standards Item No Product Name Sizes South Africa Standards International Standards According to en 14683 Surgical Masks- Requirements and Test Methods, Surgical Masks are Classified into Three Types, Type I, Type Ii and Type Iir. Type Ii and Type Iir are Applied to Medical Staff. The Chinese Standards of Yy 0469-2011 and Yy/T 0969-2013 Cover the Classification and Requirements Describes in en 1483 3 Gown: Cotton Large/ Extra Large Sabs 1401 Part I and Iv Type P 48. 100% Cotton and Fully Pre-Shrunk Sahpra: Class a Non- Sterile- Exclusion from Sahpra 4 Gown: Reusable, Water Resistant Large, Extra Large Sans 53795 and Iso 5099 for Water Resistance Sahpra: Class a Non- Sterile- Exclusion from Sahpra Licence Iso 16604 and Astm 1671 5 Gown: Disposable (Isolation) Large Extra Large Sans 53795 as Per Standard Performance (Fluid Penetration Resistance= 20cm) Surgical Drapes, Gowns and Clean Air Suits, Used as Medical Devices for Patients, Clinical Staff and Equipment- General Requirements for Manufacturers, Processors and Products, Test Methods, Performance Requirements and Performance Levels Sahpra: Class a Non-Sterile- Exclusion from Sahpra Licence *Eu Ppe Regulations 2016/4325 and Eu Mdd Directive 93/42/Eec *Fda Class I or Ii Medical Device, or Equivalent *Who Spec: (Aami pb70 All Levels Acceptable (Level 2 Fluid Penetration Resistance= 20cm; Level 3 Fluid Penetration Resistance= 50cm, or Equivalent) Iso 13688:2013, Protective Clothing- General Requirements (Also Provides Information Which must be Specified on the Order) En13795- as Adopted by Sans 6 Aprons One Size: Cover Entire Front and Sits High on Chest None Sahpra: Class a Non-Sterile- Exclusion from Sahpra Licence Iso 13688: 2013 (en) 7 Gloves, Examination, Non-Sterile, Nitrile Small, Medium, Large, Extra Large The Examination Nitrile Gloves must be Sabs or Iso Certified (Sans 11193 -1:2010) for Gloves Made Primarily from Nitrile Rubber Latex, Polychloroprene Rubber Latex, Styrene- Butadiene Rubber Solution, Styrene -Butadiene Rubber Emulsion or Thermoplastic Elastomer Solution Sahpra Class a Non-Sterile- Exclusion from Sahpra Licence *Eu Mdd Directive 93/42/Eec Category Iii *Eu Ppe Regulation 2016/425 Category Iii *en 455 *en 374 *Ansi/Isea 105 *Astm d6319, or Equivalent 8 Gloves, Examination, Non-Sterile, Latex Small, Medium, Large, Extra Large Non-Sterile Gloves must Comply with and be Tested According to the Test Methodology Provided in Sans 11193-1:2010 Single Use Medical Examination Gloves Part 1: Specifications for Gloves Made from Rubber Latex or Rubber Solution Sahpra: Class a Non-Sterile- Exclusion from Sahpra Licence 9 Goggles One Size Sans 1404, Eye- Protectors for Industrial and Non-Industrial Use Sans 50166 *Eu Ppe Regulations 2016/425 *en 166 *Ansi/Isea z87.1 or Equivalent Ce/Fda/ Ansi z87.1 10 Face Shield Full Facepiece Length that Extends to the Bottom of the Chin, Face/ Neck Length that Also Covers the Anterior Neck Area Sans 1404, Eye-Protectors for Industrial and Non-Industrial Use Amended Test Methods. Sans 50166 Sahpra Class a Non-Sterile- Exclusion from Sahpra Licence *Eu Ppe Regulations 2916/425 *en 166 *Ansi/Isea z87.1 or Equivalent Ansi z87.1-2003 (Occupational and Educational Eye and Face Protection) Eu Standard Directive 86/686/Eec, en 166/2002, Ansi/Isea z87.1-2010, or Equivalent Iso Scope of work/ key deliverables The appointed professional service provider will be expected to render quality assurance services to: · Conduct necessary tests to ensure that the PPE supplied to health facilities meets the required quality standards. · Inspection and sampling of the PPE items at the site of manufacture or storage. · Ensure quarantine of the PPE items at the suppliers- respective warehouse/s. · Produce a comprehensive unbiased report on each PPE batch tested. · Communicate results of the tests to Isibani Development Partners and NDoH. Briefing session requirements There will be a virtual briefing session for this bid which will take place on Thursday 9 December 2021 @ 10:00am via zoom. Join Zoom Meeting: https://zoom.us/j/94247021718?pwd=Y005dTljTmp1bWdoRVpjU3FCWS9Tdz09 Meeting ID: 942 4702 1718 Passcode: QijK98 Any clarity seeking questions should be sent by email to rfp@isibani.org.za .The closing date for receipt of all enquiries is five (5) days before the closing date of the bid. All enquiries received after will not be considered. All proposals accompanied by all documents that qualify the applicant as an authorized entity to do business with Isibani Development Partners, should be submitted by email to rfp@isibani.org.za by 21 December 2021 at 12h00 South African time. Please ensure the subject line states ISI2021“QUALITY ASSURANCE SERVICES FOR PPE”. Late submissions will not be considered and only selected applicants will be contacted and/or advised of the outcome.
• Documents:

 Tender Notice