CSIR Summit 2015 PPE Summit

Maryna de Lange B.Cur. Ed et Admin; RN; RM; ORN Clinical Specialist & Product Manager Halyard Health

Status of the South African Bureau of Standards (SABS)

Overview

• The South African Bureau of Standards (SABS) was established in terms of the Standards Act, 2008 (Act No. 5 of 2008), as amended.

• The mandate of the SABS in terms of the Act is to be the national institution for the development, promotion and maintenance of standardisation and quality related to commodities and the rendering of related conformity assessment services.

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Status of the South African Bureau of Standards (SABS) The South African Bureau of Standards is responsible for regulating the quality of South African goods and services.

- The Commercial Services Division is responsible for certification and training in various industries throughout South Africa.

- The Standards Division provides standards that enhance the competitiveness of South Africa, and which provide the basis for consumer protection, health, safety and environmental issues.

- The Design Institute promotes the benefits of design in order to foster the economic and technological development in South Africa. The Institute focuses on design education, industry and information, and includes a number of award schemes and design publications.

- The Regulatory Division administers approximately 70 legal compulsory specifications across a wide spectrum of areas. These compulsory specifications are legal measures and requirements to ensure that products locally manufactured or imported into South Africa or exported from South Africa meet the

minimum requirements for health and safety as set out in the relevant South African National Standards.

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Definitions

Standard

• document that provides for common and repeated use, rules, guidelines or characteristics for products, services, or processes and production methods, and includes terminology, symbols, packaging, marking or labelling requirements as they apply to a product, service, process or production method

Technical committee (TC)

• national technical committee group of representatives that is concerned with standardization, that is responsible for identifying the need for, and the preparation of, South African National Standards and other normative and non-normative documents in a defined field and that reflects national interests within that field

Working group (WG)

• group of subject matter experts appointed by a TC or SC to deal with a particular project or with a particular aspect of a project

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Stages of standards development

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SANS 1866 -1 and part 2

• SANS 1866 -1 and part 2 are being developed by SABS TC 1039 Medical Devices under Natural Science department (Food and health standards).

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SANS1866-1:2014 Medical Face Masks

Scope

This standard covers the minimum performance requirements for materials used in the construction of medical face masks, intended to limit the transmission of infective agents in the healthcare environment.

This specification provides classification of performance for a range of medical face mask materials. Medical face mask performance classes are based on the barrier performance properties of the medical face mask materials (fluid resistance, bacterial filtration efficiency, and sub-micron filtration efficiency).

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ASTM F2100-11 & SANS 1866-1:2014

Characteristic Level 1 Barrier

Level 2 Barrier

Level 3 Barrier

Bacterial Filtration efficiency, % ≥ 95 ≥ 98 ≥ 98

Differential pressure, mm H2O/cm2 < 4.0 < 5.0 < 5.0

Sub-micron particulate filtration efficiency at 0.1 micron %

≥95 ≥ 98 ≥ 98

Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result

80 120 160

Flame spread

Class 1a Class 1a Class 1a

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60 days

21 days

SANS1866-1:2014 Medical Face Masks

SANS 1866-2: 201X Medical respirators

Introduction

• Air purifying medical respirators provides a barrier to prevent health care workers from inhaling infective airborne agents such as bacteria and viruses. The level of protection a respirator provides is determined by the efficiency of the filter material and how well the face piece fits or seals to the health care workers face. A number of studies have shown that surgical masks will not provide adequate protection in filtering out the infective airborne agents. Additionally, surgical masks are not respirators therefore, are not certified and do not satisfy requirements for respiratory protection.

• Approved respirators are designed to have the characteristics of both an approved respirator and surgical mask. In the US these products typically referred to as “Surgical respirators” are both approved by NIOSH and cleared by the US food and drug administration (FDA) for use in surgery. In Europe, these products typically referred to “Health care respirators” are tested to both EN 149:2001 + A1:2009 and EN 14683:2005 and approved to both the European medical device and PPE directives.

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SANS 1866-2: 201X Medical respirators

Scope

• This standard covers the material and performance requirements for medical respirators, intended to limit the transmission of infective agents in the healthcare environment.

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SANS 1866-2: 201X Medical respirators

Criteria

• The ability to filter particles 1 mm in size in the unloaded state with a filter efficiency of > 95 % (i.e., filter leakage < of 5 %), given flow rates of up to 85 L per minute

• The ability to be qualitatively or quantitatively fit tested in a reliable way to obtain a face-seal leakage of < 10 %

• The ability to fit the different facial sizes and characteristics of health care workers, which can usually be met by making the respirators available in more than one shape or size.

• The ability to be checked for face piece fit, in accordance with standards and good hygiene practice, by health care workers each time they put on their respirators

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International Guidelines

1. FDA - The Food and Drug Administration USA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Respiratory Protective Devices

42 CFR Part 84

- AGENCY: National Institute for Occupational Safety and) Health (NIOSH)

- Centres for Disease Control and Prevention, Public Health Service, HHS

2. EUROPEAN STANDARD

- Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking

149:2001+A1:2009

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Stages of standards development

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60 days

1 year

21 days

2 years

SANS 1866 Working Group

• Trade / Manufacturers

Kimberly Clark

3M

Respitek

• Healthcare Providers

Netcare

LHC

MediClinic

• Department of Health

• Department of Trade and Industry

• SABS commercial

• NIOH

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