DRAFT TANZANIA STANDARD  
 
 
 
 
                     GDC 4 (1 95) DTZS Sharps container - Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 
 
© TBS 2022 — all rights reserved                                   1st Edition  
 
 EXECUTIVE SUMMARY OF  GDC 4 (195) DTZS SHARPS CONTAINER - 
SPECIFICATION  
This Tanzan ia Standard spec ifies requiremen ts and test methods for sharps 
containers intended to hold potent ially infectious medical waste compr ised largely of 
devices, which can readily cause physical injury, e.g. scalpels , blades , hypode rmic 
needles and syringes . This Tanzan ia Standard covers sharps container that are 
suppl ied complete by the manufacturer and those that are supplied a s components 
intended to be assembled by the user . 
 
No limitation in size of containers is specified in this Tanzania Standard and no 
requirements are included for materials of construction. However, the materials used 
should be such that the containers can be disposed by incineration.  
 
It is anticipated that this draft Tanzania Standard will be made COMPULSORY i n its 
application.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
1. Scope  
 
This Tanzan ia Standard spec ifies requiremen ts and test methods for sharps 
containers intended to hold potent ially infectious medical waste compr ised largely of 
devices, which can readily cause physical injury, e.g. scalpels , blades , hypode rmic 
needles and syringes . This Tanzan ia Standard covers sharps container that are 
suppl ied complete by the manufacturer and those that are supplied as components 
intended to be assembled by the user . 
 
No limitation in size of containers is specified in this Tanzania Standard and no 
requirements are included for materials of construction. Howeve r, the materials used 
should be such that the containers can be disposed by incineration.  
2. Normative references  
The following documents are 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 applies. For undated references, the latest edition of the referenced 
document (including any amendments) applies.  
TZS 993 -2: 2007/ISO 7886 -2:2020 Sterile hypodermic syringes for single use - 
part 2: s yringes for use with power -driven syringe pumps  
TZS 2165:2018/ISO 31000 Risk management -Guidelines.  
TZS 517:1992/ISO 2248:1985 Packaging - Complete, filled transport packages 
- Vertical impact test by dropping.  
3. Terms and definitions  
For the purpose of this document, the following terms and definitions shall apply;  
 
3.1 sharps container  
container that is filled with used medical instruments such as needles and other sharp 
medical instruments  
 
3.2 sharps  
 objects capable of cutting or penetrating skin  
EXAMPLE: Needles of various types, syringes, scalpels, broken glass, culture 
slides, culture dishes, broken capillary tubes, broken rigid plastic, exposed ends 
of dental wires.  
 
3.3 handle  
appendage, protrusion, flange or recess intended for lifting the contai ner  
 4. Requirements  
4.1 General Requirements  
 
4.1.1  The principles of risk assessment in accordance with TZS 2165:2018/ISO 
31000:2018, as well as human factors, should be considered in the design 
process of sharps containers. The base dominant colour should be yellow 
unless local regulations state otherwise. Fill level visibility shall be one of the 
design goals for the containers.  
 
4.1.2  The mater ials chosen for the construct ion of t he sharps container shall be 
completely combust ible. 
 
4.1.3  The backgro und colour of the walls of the sharps c ontainer shall be ye llow. 
4.1.4  Sharps container shall be fitted with a sharps aperture, capable of receiving 
syringes and needle assemblies of all standard sizes up to and including 20 ml, 
together with other sharps. It mus t be possible to close and seal the aperture 
at any time between empty and full to maximum capacity.  
 
4.1.5  Sharps container shall be supplied with a handle or other lifting device which 
allows the container to be carried safely with one hand. It must remain att ached 
to the box when the box is filled with sharps to its maximum capacity.  
 
4.2 Specific Requirements  
 
4.2.1  Handle  
 
Sharps container shall be p rovided with a handle (s) that is not part of the closure 
device . When tested as descr ibed in annex A , the hand le(s) shall remain intact and 
there shall be no  separation of the hand le (s) from the conta iner. 
 
4.2.2   Aperture and closu re 
 
A dev ice intended to c lose the aperture sha ll be provided attached to the sha rps 
container . When tested as desc ribed in annex B , no par t of the conta iner shall 
become detached . 
 
NOTE - It should be possible to place items intende d for di sposal into the sharps 
container w ithout  
contaminat ing the outs ide of the containe r. 
 
4.2.3  Resistance to penetration  
When tested as described in annex C, the averages of the forces needed to 
penetrate samples taken from:  
a) the base  
b) the side walls  
c) the closure and   
 d) the top, excluding the closure,  
shall be not less than 15 N and the force needed to penetrate anyone sample from 
wherever shall be not less t han 12.5 N.  
4.2.4  Resistance to damage during drops from height  
When tested as described in TZS 517:1992/ ISO 2248:1985 there shall be no evidence 
of leakage from any parts of the sharps containers and the containers and closures 
shall remain intact.  
4.2.5  Container stability  
The container shall not topple over when tested in accordance with Annex G.  
NOTE;  Containers recommended for use with a wall mount and pocket collectors 
are excluded from the requirement specified in 4.2.5. The requirement 
applies to c ontainers intended for use on a horizontal surface. Sharps 
containers intended to be used with a secondary stabilizer shall be tested 
in conjunction with that device.  
Sharps containers (except pocket collectors) equipped with a needle 
disconnection feature  shall have a means whereby the disconnection 
procedure is achieved with one hand.  
4.2.6  Water resistance  
For sharps containers filled to their maximum capacity, must be able to withstand 48 
hours at 43°C and 90% relative humidity in 5 mm of water, without spilling any part of 
the load when tested with accordance with Annex E.  
4.2.7  Temperature resistance  
For sharps containers made from Cardboard boxes, filled to their maximum capacity, 
must be able to resist temperatures of up to 170°C for periods up to 3 0 minutes without 
spilling any part of the load when tested with accordance with Annex F.  
5. Marking  
 
  Sharps container shall be permanently and legibly marked or labeled with at least 
the following:  
 
a) The word 'BIOHAZARD and its symbol ' prominently displaye d in upper 
case letters not less than 10 mm h igh; 
 
b) The words 'USED SHARPS ONLY ' in letters not less than 7 mm high but 
smaller than the word 'BIOHAZARD '. 
 
c) The words 'DESTROY BY INCINERATION ' or 'TO BE INCINERATED ' in 
letters not less than 7mm high but smaller than the word 'BIOHAZARD '. 
 
d)  A horizontal line to indicate when the sharps container is filled to between 
70 % and 80 % of the maximum volume of the container as stated by the 
manufacturer [see clause 6 (c) 1, together with the wo rds' DO NOT FILL  
 ABOVE THE LINE ' in letters not less than 7 mm high but smaller the word 
'BIOHAZARD '. 
 
e)  The name and/or trade mark of the manufacturer or supplier in letters , or 
by means of symbols , not higher than the wo rds specified i n 5 (c);  
 
 
f)  Identification reference to the batch or date of manufacture . If the sharps 
container is intended to be assembled by the user, an identification 
reference to the batch or date of manufacture shall be marked on each 
component supplied for assemb ly. 
 
g) Material used for construction of container.  
 
h) Capacity of the containers in Litres.  
 
6.  Information's to be provided by the manufacturer  
 
              The manufacturer shall provide the following information with each sharps 
container;  
a) If the sharps container is in tendered to be assembled by the user, 
instructions for assembly of the components  
 
b)  Instructions for use of the sharps container including any restrictions on 
use and any warning to the user of precautions needed in using the 
containers.  
 
c) The recommended maximum volume (nominal volume) of sharps 
containers  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 Annex A  
 
Normative  
 
(clause 4.2.1)  
 
Method of test for security and strength of the handle (s)  
 
 
A-1 Fill the sharps container w ith any su itable mater ial such tha t the mass of conten ts, 
expressed in k ilograms , is numer ically equa l to the maximum volume of the container 
as stated by the manufacturer expressed in liters. 
 
A-2 Suspend the conta iner by its handle (s) at the intended ca rrying po int (s) from a 
rigid suppo rt for 1 h at a temperatu re of 25 °C ± 5 °C. 
 
A-3 Remove the conta iner from the suppor t and inspec t the handle (s) for integr ity and 
any evidence o f separat ion of the handle (s) from the container. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
Annex B  
 
Normative  
 
(clause 4.2.2)  
 
Method of test for security of attachm ent of aperture closure devices  
 
 
B-1 Carry out the test descr ibed in TZS 517 and annex E but use sharps conta iners 
that are empty and which have the aperture closure attached as suppl ied by the 
manufacture , not closed or locked . 
 
B-2 After the test , inspect the s harps con tainer to establish whethe r any par ts of it 
have become detached . 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 Annex C  
 
Normative  
 
(clause 4.2.3)  
 
Resistance to penetration  
 
C.1 Apparatus  
 
C-1.1 Testometer  
 
having a load cell capable o f measu ring the fo rce appl ied to a needle penetrating a 
samp le with means to record the force necessary jus t to pe netrate one surface of the 
sample when the needle is pressed into the othe r surface . 
 
C-1.2 Hypodermic needles  
 
size 0.8 mm x 25 mm or 0 .8 mm x 40 mm . Confor ming to the requirements provided 
in TZS 993 -2: 2007.  
 
        NOTE - Any lubr icant should be removed using a suitable so lvent. 
 
C-1.3 Sample supp ort 
 
12.5 mm deep with a ho le, 6 mm in diameter , in its centre , 
 
C-2 Procedure  
 
C-2.1 Cut samples , 12 mm x 12 mm , from the sha rps con tainer , 12 pieces from the 
base , 12 pieces from the s ide walls , 12 pieces from the top , excluding the clos ure. If 
due to the s ize of the conta iner it is not poss ible to c ut the required numbe r of samp les 
from one conta iner, cut the maximum number poss ible from one conta iner and cut the 
remaining numbe r from the m inimum n umber of furt her conta iners. 
 
C-2.2. Condit ion the samples at 20°C ± 5 °C an d a relative humid ity of 50 ± 5 % relative 
humidity for at least 2 h and carry out the test unde r the same cond itions. 
 
C-2.3 Secu re a hypodermic needle (C-1.2) in the needle holder . Place one samp le 
suppo rt (C-1.3) with the inside surface facing upwards and locate it centrally on the 
table of the testomete r (C-1.1). Do not distort the samp les by at tempt ing to f latten any 
curves . 
 
C-2.4 Lowe r the needle towards the sample at a rate of 100 mm/min and at an angle 
of 90° ± 5° . Allow the needle to pass through the samp le and reco rd the fo rce 
necessary just to pe netrate under surface of the samp le. 
 
C-2.5 Repea t the procedure desc ribed in C-2.3 and C-2.4 for each of the remain ing 
sample , using a new hypodermic needle to penetrate each sample .  
  
C-2.6 Calculate the ave rages of the fo rces recorde d to penetra te the samples taken 
from; 
a) the base ; 
b) the side wal ls; 
c) the closure and  
d) the top, excluding the closure. 
 
 
Annex E  
 
Normative  
 
(clause 4.2.6)  
 
Water resistance test  
 
 
E-1. Assemble and load the box to its maximum capacity. Close and seal the aperture 
in accordance with the pictorial instructions on the box.  
 
E-2. Set a test chamber temperature to 43°C and 90% relative humidity. Place the 
loaded box in a tray of water 5mm deep for 48 hours. Maintain the water level 
throughout this period.  
 
E-3. Remove the box from the water tray and re cord its condition.  
 
E-4. Shake the box strongly 20 times, using an up and down motion. Record any 
spillage or needle penetration.  
 
E-5.  No spillage of contents or needle penetration.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
Annex F  
 
Normative  
 
(clause 4.2.7)  
 
Temperature resistance test  
 
F-1 General  
F-1-1 This  test should be applicable to sharps container made of Cardboard 
boxes only.  
 
F-2 Assemble  and load the box.  
 
F-3 Place  the loaded container in a test chamber at 170°C for 30 minutes.  
 
F-4 Remove  and inspect the container.  
 
F-5 No spillage of the contents. Distortion of the container is acceptable.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
Annex G  
 
Normative  
 
   (clause 4.2.5)  
 
Container stability  
 
 
G-1 Fill one container to the fill line with material of a density of (0.20 ± 0.01) kg/l 
or with syringes with a capacity of ≤ 2 ml. Do not lock or close the permanent or 
temporary closures.  
 
G-2 Place the container in the most adverse position on its base for toppling on a 
surface with a minimum inclination angle of 15°. Ensure that the container does 
not slide before toppling.  
 
G-3 Check for conformity with clause 4.2.5.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 Bibliography  
 
TZS 501: 2010, Quality management systems – Requirements  
 
TZS 504: 2010, Managing for the sustained success of an Organization - A quality 
management approach  
 
ISO 23907 -1:2019 Sharps injury protection — requirements and test methods — 
part 1: single -use sharps containers