Final Draft Uganda Standard Fdus 966-3: 2011

FDUS 966-3 FINAL DRAFT UGANDA

STANDARD First Edition 2011-mm-dd

Medical devices — Surgical gowns, drapes and clean air suits, — Part 3: Performance requirements and performance levels

Reference number FDUS 2011-3: 2011

FDUS 966-3: 2011

Compliance with this standard does not, of itself confer immunity from legal obligations

A Uganda Standard does not purport to include all necessary provisions of a contract. Users are responsible for its correct application

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written permission from UNBS.

Requests for permission to reproduce this document should be addressed to

The Executive Director Uganda National Bureau of Standards P.O. Box 6329 Kampala Uganda Tel: 256 414 505 995 Fax: 256 414 286 123 E-mail: [email protected] Web: www.unbs.go.ug

FDUS 966-3:2011

Foreword

Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade and Industry established under Cap 327, of the Laws of Uganda. UNBS is mandated to co-ordinate the elaboration of standards and is (a) a member of International Organisation for Standardisation (ISO) and

(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and

The work of preparing Uganda Standards is carried out through Technical Committees. A Technical Committee is established to deliberate on standards in a given field or area and consists of representatives of consumers, traders, academicians, manufacturers, government and other stakeholders. Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the general public for comments. The committee reviews the comments before recommending the draft standards for approval and declaration as Uganda Standards by the National Standards Council. Committee membership

The following organisations were represented on the Medical Devices Standards Technical Committee (UNBS/TC 16) during the development of this standard:

 Government Analytical Laboratory  Joint Medical Stores (JMS)  Makerere University School of Publics Health (MUSPH)  Meridian Techsystem (MTS)  Ministry Of Health (MOH)  Mulago Hospital Complex  National Drug Authority (NDA)  National Medical Stores (NMS)  Paragon Hospital  Uganda National Bureau of Standards (UNBS)

FDUS 966-3: 2011

Introduction

The series of US 966 specifies requirements for single-use and reusable coverings (surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent transmission of infected agents between patients and clinical staff during invasive surgical procedures.

The general requirements for gowns, drapes and clean air suits used as medical devices for patients and clinical staff are specified in US 966-1. In this respect, US 966-1 specifies the relevant characteristics to be evaluated for products covered by the Uganda standard. US 966-2 specifies the test methods for evaluating these characteristics.

NOTE For more information for products contained within the scope of this Uganda standard, it is recommended to refer to US 966-1.

FINAL DRAFT UGANDA STANDARD FDUS 966-3: 2011

Medical devices — Surgical gowns, drapes and clean air suits, used— Part 3: Performance requirements and performance levels

1 Scope

This part of FDUS 966-3 specifies performance requirements for surgical drapes, gowns and clean air suits.

Note General performance requirements are specified for various characteristics in US 966-2, ISO 22610 and ISO 22612

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

FDUS 966-1, Medical devices — Surgical gowns, drapes and clean air suits, used as medical devices — Part 1: General requirements

FDUS 966-2, Medical devices — Surgical gowns, drapes and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods

ISO 9073-11, Textiles – Test method for nonwovens – Part 11: Run off

ISO 9073-12, Textiles – Test method for nonwovens – Part 12: Demand absorbency

ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 11607-1, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-2, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

3 Terms and definitions

For the purposes of this standard, the following terms and definitions shall apply.

3.1 less critical product area product area less likely to be involved in the transfer of infective agents to or from the wound

NOTE 1 For the definition of critical product area, please see US 966-1.

NOTE 2 If the manufacturer differentiates between critical and less critical areas of the product, US 966-1 requires the manufacturer to identify these areas, and if requested should supply information on the rationale for this distinction.

3.2 performance level refer to products designated as standard or high performance according to close 4 of this standard

FDUS 966-3: 2011

NOTE With the introduction of two performance levels, the US 966 series of standards acknowledges the fact that products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress and liquid challenge throughout the surgical procedure.

3.2.1 standard performance classification addressing minimum performance requirements for various characteristics of products (see clause 4) used as medical devices in invasive surgical procedures

3.2.2 high performance classification addressing elevated performance requirements for various characteristics of products (see clause 4) used as medical devices in invasive surgical procedures

NOTE Examples of surgical procedure where elevated performance level should be considered are those where extensive exposure to liquid, mechanical stresses or those where longer procedures can be expected.

3.3 product surgical gowns, surgical drapes including equipment covering and clean air suits

4 Performance requirements

To comply with the US 966 series of standards, products shall meet all the requirements specified in either Table 1, 2 or 3 (as appropriate to products), when tested according to US 966-2 throughout their useful life.

Note1 General Requirements and guidance for manufacturers, processors and products, and the information to be supplied for the manufacturing, processing and testing are given in US 966-1

Note 2 Test methods for evaluation of all characteristics are given in US 966-2, ISO 22610 and ISO 22612

Note 3 Performance requirements are specified depending on product area and performance level. However, for some characteristics, the performance requirement will apply for all performance levels and products areas of the medical device.

FDUS 966-3: 2011

Table 1 — Performance requirements for surgical gowns

Characteristics Units Requirements Standard performance High performance Critical product Less critical Critical product Less critical area product area area product area

a, c a, c Resistance to microbial Log10 Not required ≤ 2 Not required ≤ 2 penetration – dry (CFU) Resistance to microbial BI ≥ 2.8 b Not required 6.0 b d Not required penetration – wet c c c c Cleanliness – microbial Log10 ≤ 2 ≤ 2 ≤ 2 ≤ 2 (CFU/dm2) Cleanliness- particulate IPM ≤ 3.5 ≤ 3.5 ≤ 3.5 ≤ 3.5 matter Linting Log10 (lint ≤ 4.0 ≤ 4.0 ≤ 4.0 ≤ 4.0 count)

Resistance to liquid Cm H2O ≥ 20 ≥ 10 ≥ 100 ≥ 10 penetration Bursting strength – dry kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40 Bursting strength – wet kPa ≥ 40 Not required ≥ 40 Not required Tensile strength – dry N ≥ 20 ≥ 20 ≥ 20 ≥ 20 Tensile strength – wet N ≥ 20 Not required ≥ 20 Not required a Test conditions: challenge concentration 10B CFU/g talc and 30 minutes vibration time b The least significant difference (LSD) for BI (Barrier Index) when estimated using ISO 22610 was found to be 0.98 at 98 % confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by up to 0.98 BI are probably not different. Materials varying by more than 0.98 BI are probably different. (The 95 % confidence level means that an observer would be correct 19 times out of 20 to accept these alternatives) c For the purpose of this standard, log10 CFU ≤ 2 means maximum 300 CFU d BI (Barrier Index)= 6.0 for the purpose of this standard means; no penetration, BI = 6.0 is the maximum achievable value.

FDUS 966-3: 2011

Table 2 — Performance requirements for surgical drapes Characteristics Units Requirements

Standard performance High performance

Critical Less critical Critical Less critical product area product area product area product area

a, c a, c Resistance to microbial Log10 Not required ≤ 2 Not required ≤ 2 penetration – dry (CFU)

Resistance to microbial BI ≥ 2.8 b Not required 6.0 b d Not required penetration – wet

c c c c Cleanliness – microbial Log10 ≤ 2 ≤ 2 ≤ 2 ≤ 2 (CFU/dm2)

Cleanliness- particulate IPM ≤ 3.5 ≤ 3.5 ≤ 3.5 ≤ 3.5 matter

Linting Log10 (lint ≤ 4.0 ≤ 4.0 ≤ 4.0 ≤ 4.0 count)

Resistance to liquid Cm H2O ≥ 20 ≥ 10 ≥ 100 ≥ 10 penetration

Busting strength – dry kPa ≥ 40 ≥ 40 > 40 ≥ 40

Busting strength – wet kPa ≥ 40 Not required ≥ 40 Not required

Tensile strength – dry N ≥ 15 ≥ 15 ≥ 20 ≥ 20

Tensile strength – wet N ≥ 15 Not required ≥ 20 Not required a Test conditions: challenge concentration 108 CFU/g talc and 30 minutes vibration time b The least significant difference (LSD) for BI when estimated using ISO 22610 was found to be 0.98 at 98 % confidence level. This is the minimum difference need to distinguish between two materials thought to be different. Thus materials varying by up to 0.98 BI are probably not different. Materials varying by more than 0.98 BI are probably different. (The 95 % confidence level means that an observer would be correct 19 times out of 20 to accept these alternatives) c For the purpose of this standard, log10 CFU ≤ 2 means maximum 300 CFU d BI (Barrier Index) = 6.0 for the purpose of this standard means; no penetration, BI = 6.0 is the maximum achievable value.

FDUS 966-3: 2011

Table 3 — Performance requirements for clean air suits

Characteristics Unit Requirement b

a c Resistance to microbial penetration – dry Log10 (CFU) ≤ 2 2 C Cleanliness – microbial Log10 (CFU/dm ) ≤ 2 Cleanliness – particulate matter IPM ≤ 3.5 Linting Log10 (lint count) ≤ 4.0 Busting strength – dry kPa ≥ 40 Tensile strength – dry N ≥ 20

a Test conditions: challenge concentration 108 CFU/g talc and 30 minutes vibration time

b Performance requirements apply for all areas of clean air suits, as clean air suits should be used in addition to surgical gowns and not as substitute.

c For the purpose of this standard, log10 CFU ≤ 2 means maximum 300 CFU

5 Packing and marking

5.1 Packing

The number of products per package and the type of package shall be as specified by the purchaser. The packages shall be packed in accordance with ISO 11607 series. Only products of the same type and nominal size shall be packed together in a package and in a bulk container. Sterile-packed packages shall be packed in separate bulk containers.

5.2 Marking

5.2.1 Packages

In addition to the requirements of US 966-1 (clause 4), the following information shall appear in legible and indelible marking on each package of product or on a label securely attached to the package:

a) the manufacturer's name, address and trade mark;

b) the name of product;

c) in the case of a sterile-package, the word "sterile";

d) the quantity of product;

e) the batch identification number;

f) date of manufacture and conditions of storage

g) country of origin

5.2.2 Additional marking

When so specified by the purchaser, packages shall bear information additional to that required in terms of 5.2.1.

FDUS 966-3: 2011

Bibliography

[1] EN 13795 -2, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipments – Part 2: Test methods

[2] ISO 22612, Clothing for protection against infectious agents – Test method for resistance to dry microbial penetration

FDUS 966-3: 2011

Certification marking

Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards (UNBS) Certification Mark shown in the figure below.

The use of the UNBS Certification Mark is governed by the Standards Act, and the Regulations made thereunder. This mark can be used only by those licensed under the certification mark scheme operated by the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The presence of this mark on a product or in relation to a product is an assurance that the goods comply with the requirements of that standard under a system of supervision, control and testing in accordance with the certification mark scheme of the Uganda National Bureau of Standards. UNBS marked products are continually checked by UNBS for conformity to that standard.

Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda National Bureau of Standards.

FDUS 966-3: 2011

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