DRAFT UGANDA STANDARD  
  DUS 2140  
First Edition  
2019 -mm-dd 
 
 
 Reference number  
DUS 2140 : 2019 
© UNBS 2019  
  
Guideline on use of the ISO 7886 and ISO 7864 standards for 
hypodermic syringes and hypodermic needles  
 DUS 2140: 2019  
ii © UNBS 2019  – All rights reserved  
 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  
© UNBS 2019   
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, includ ing 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 41 4 333 250/1/2/3  
Fax: +256 41 4 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  
 
 DUS 2140: 2019  
© UNBS 2019  – All rights reserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade , Industry and 
Cooperatives established unde r Cap 327 , of the Laws of Uganda , as amended .  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  
(c) the National Enquiry Point on TBT  Agreement  of the World Trade Organisation (WTO).  
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a give n field or area and consists of key stakeholders 
including government, academia, consumer groups, private sector and other interested parties.  
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.  
The committee responsible for this document is Technical Committee UNBS /TC 14, Medical devices . 
  DRAFT UGANDA STANDARD  DUS 2140: 2019  
 
© UNBS 2019  – All rights reserved  1 
 Guideline on use of the ISO 7886 and ISO 7864 standards for 
hypodermic syringes and hypodermic Needles  
1 Scope   
This Draft Uganda standard covers guidelines on how to use the ISO 7886  and ISO 7864  standard s for 
hypodermic syringes and Hypodermic Needles respectively.  
This guidance standard provides sampling and acceptance criteria for ISO 7886 for hypodermic syringes and 
ISO 7864 for hypodermic n eedles standards .  
This standard also clarifies on when the auto -disable feature on hypod ermic syringes is a requirement  
2 Normative references     
The following referenced documents referred to in the text in such a way that some or all of their content 
constitutes requirements of this document. For dated references, only the edition cited app lies. For undated 
references, the latest edition of the referenced document (including any amendments) applies.  
US 7886  (all parts), Sterile hypodermic syringes for single use  
US ISO 7864, Sterile hypodermic needles for single use -- Requirements and test method s 
ISO 2859 -1, Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
3 Terms and definitions   
For the purposes of this document, the following terms and definit ions apply. ISO and IEC maintain 
terminological databases for use in standardization at the following addresses: — ISO Online browsing 
platform: available at http://www.iso.org/obp  
3.1  
auto disable feature  
feature that automatically activates upon or duri ng administration of the intended dose to prevent subsequent 
re-use of the syringe  
3.2  
auto disable syringes  
syringes that cannot be reused. They incorporate a mechanism to automatically break or lock the plunger 
when the injection is given to make the s yringe inoperable for being used for second time.  
4 Requirements  
4.1 All hypodermic syringes with less than 20mL capacity are required to have an auto-disable feature.  DUS 2140 : 2019  
2 © UNBS 2019  – All righ ts reserved  
 4.2 The auto-disabled  syringes shall be for single use.  
5 Sampling and acceptance criteria for hypodermic syringes   
For reference purposes, hypodermic syringes shall be sampled  and inspected in accordance with ISO 2859 -1. 
The inspection  levels and acceptance quality limits (AQLs) shall conform to those specified in Table 1 for the 
character istics  listed.  
When a lot size c annot be determined, a lot of 10 001 to 35  000 shall be assumed.  
Table 1— Sampling and acceptance criteria for hypodermic syringes  
Attribute  Inspection Level  AQL  
Cleanliness   8 Hypodermic Syringes  All pass  
Re-use preventio n feature  General Inspection Level 1  4.0 
Freedom from air and liquid leakage  General Inspection Level 1  4.0 
Tolerance for graduated capacity  8 Hypodermic Syringes  All pass   
Dead space  General Inspection Level 1  4.0 
Packag ing and labelling  8 Hypodermic  Syringes  All pass  
Extractable metals  8 Hypodermic Syringes  All pass  
 
6 Sampling and acceptance criteria for hypodermic needles  
For reference  purposes , hypodermic Needles shall be sampled  and inspected in accordance with ISO 2859 -1. 
The inspection  levels  and acceptance quality limits (AQLs) shall confo rm to those specified in Table 2  for the 
characteristics  listed.  
When a lot size c annot be determined, a lot of 10 001 to 35  000 shall be assumed.  
Table 2 — Sampling and acceptance criteria for Hypodermic Ne edles  
Attribute  Inspection Level  Acceptance Criteria  
Cleanliness  8 Hypodermic Needles  All Shall pass  
Needle Tube -Length  8 Hypodermic Needles  All shall comply  
Freedom from Defects (Needle Tube)  General Inspection Level 1  AQL of 1.5 
Lubricant (Needle Tu be) 8 Hypodermic Needles  All shall comply  
Needle Point  General Inspection Level 1  AQL of 0.4  
Bond between Hub and Needle Tube  General Inspection Level 1  AQL of 1.5 
Patency of Lumen  General Inspection Level 1  AQL of 1.5 DUS 2140: 2019  
© UNBS 2019  – All rights reserved  3 
 Bibliography  
[1] Demographic and  Health Survey , 2006  Uganda.  
[2] National Policy on injection safety and health care waste management, July 2004, Ministry of Health , 
Republic of Uganda   
[3] WHO guideline on the use of safety -engineered syringes for intramuscular, intradermal and 
subcutan eous injections in health care settings, 2016 . 
 DUS 2140 : 2019  
© UNBS 2019  – All rights reserved  5 
 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 Sta ndard. 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 th e 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 lice nsing may be obtained from the Director, Uganda 
National Bureau of Standard s.  
 
 DUS 2140 : 2019    
 
ICS 11.040.20  
Price based on nn  pages  
© UNBS 2019– All rights reserved