STANDARDS
and
GUIDELINES

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^@@  Chemical treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent.
        It must be ensured that chemical treatment ensures disinfection.
**    Mutilations / Shredding must be such so as to prevent unauthorised reuse.
^@     There will be no chemical pre-treatment before incineration.  Chlorinated plastics shall not be incinerated.
*      Deep burial shall be an option available only in towns with population less than five lakh and in rural areas.
+     Option given above are based on available technologies.  Occupier/operator wishing to use other
        State-of-the-art technologies shall approach the Central Pollution Control Board to get the standards
        laid down to enable the prescribed authority to consider grant of authorisation.

 

 

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SCHEDULE II

Colour Coding	Type of Container	Waste Category	Treatment options as per Schedule I
Yellow	Plastic bag	Cat. 1, Cat. 2,  Cat. 3 and Cat. 6	Incineration/ deep burial
Red	Disinfected container/ plastic bag	Cat. 3, Cat. 6, and Cat. 7	Autoclaving/Micro waving/ Chemical Treatment
Blue/ White Translucent	Plastic Bag/ puncture proof container	Cat. 4 and Cat. 7	Autoclaving/Micro waving/ Chemical Treatment and destruction/ shredding
Black	Plastic bag	Cat.5, Cat. 9, and Cat. 10 (solid)	Disposal in secured landfill

Notes:
1.     Colour coding of waste categories with multiple treatment options as defined in Schedule I, shall be
        selected depending on treatment option chosen, which shall be specified in Schedule I.
2.     Waste collection bags for waste types needing incineration shall not be made of chlorinated plastics.
3.     Categories 8 and 10 (liquid) do not require containers/bags.
4.     Category 3 if disinfected locally need not be put in containers/bags.

 

 

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SCHEDULE III
[Rule 6 of the Biomedical (Management and Handling) Rules, 1998]

 

BIOHAZARD  SYMBOL	CYTOTOXIC HAZARD SYMBOL
BIOHAZARD	CYTOTOXIC
HANDLE WITH CARE

 Note: Label shall be non-washable and shall be prominently visible

 

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SCHEDULE V
(See Rule 5 and Schedule I)

Standards For Incinerators

      All incinerators shall meet the following operating and emission standards:

      A.  Operating standards
            1.     Combustion efficiency (CE) shall be at least 99.00 %.

            2.     The combustion efficiency is computed as follows:

                                                    %C0₂
                           C.E.   =    ----------------------    X   100
                                             %C0₂ + % CO

            3.     The temperature of the primary chamber shall be 800 +/-50 ^oC
            4.     The secondary chamber gas residence time shall be at least 1 (one) second at 1050 +/- 50 ^oC

      B.   Emission standards

Sl. No.	Parameters	Concentration, mg/Nm3 (at 12 % CO2 correction)
1.	Particulate matter	150
2.	Nitrogen oxides	450
3.	HCl	50
4.	Minimum stack height shall be 30 m above ground level
5.	Volatile organic compounds in ash shall not be more than 0.01%

   Note:

Standards For Waste Autoclaving

      The autoclave should be dedicated for the purpose of disinfecting and treating biomedical waste.
      1.  When operating a gravity flow autoclave, medical waste shall be subjected to:
            i.    A temperature of not less than 121 ^oC and pressure of 15 pounds per square inch (psi) for
                  an autoclave residence time of not less than 60 minutes; or
            ii.   A temperature of not less than 135 ^oC and a pressure of 31 psi for an autoclave residence time
                  of not less than 45 minutes; or
            iii.  A temperature of not less than 149 ^oC and a pressure of 52 psi for an autoclave residence time of
                  not less than 30 minutes.
      2.   When operating a vacuum autoclave, medical waste shall be subjected to a minimum of one
            per vacuum pulse to purge the autoclave of all air. The waste shall be subjected to the following
            i.    A temperature of not less than 121 ^oC and a pressure of 15 psi per an autoclave residence time
                  of not less than 45 minutes; or
            ii.   A temperature of not less than 135 ^oC and a pressure of 31 psi for an autoclave residence time
                  of not less than 30 minutes; or
      3.   Medical waste shall not be considered properly treated unless the time, temperature and pressure
            indicators indicate that the required time, temperature and pressure were reached during the autoclave
            process. If for any reasons, time, temperature or pressure indicator indicates that the
            required temperature, pressure or residence time was not reached, the entire lead of medical waste
            must be autoclaved again until the proper temperature, pressure and residence time were achieved.
      4.   Recording of operational parameters.
            Each autoclave shall have graphic or computer recording devices which will automatically and
            continuously monitor and record dates, time of day, lead identification number and operating
            parameters through out the entire length of the autoclave cycle.
      5.   Validation test:
            Spore testing: The autoclave should completely and consistently kill the approved biological indicator
            at the maximum capacity of each autoclave unit. Biological indicator for autoclave shall be Bacillus
            stearothermophilus spores using vials or spore strips, with at least 1*10⁴ spores per million. Under
            no circumstances will an autoclave have minimum operating parameters less than a residence time of
            30 minutes, regardless of temperature and pressure, a temperature less than 121 ^oC or a pressure less
            than 15 psi.
      6.   Routine tests
            A chemical indicator strip/tape that changes colour when a certain temperature is reached can be used
            to verify that a specific temperature has been achieved. It may be necessary to use more than one
            strip over the waste package at different location to ensure that the inner content of the package has
            been adequately autoclaved.

 

Standard For Liquid Waste

      The effluent generated from the hospital confirm to the following:

Parameter	Permissible limit
pH	6.5 – 9.0
Suspended solids	100   mg/l
Oil and grease	10     mg/l
BOD	30     mg/l
COD	250   mg/l
Bioassay test	90% survival of fish after 96 hours in 100% effluent

  These limits are applicable to those hospitals which are either connected with sewers without terminal
  sewage treatment plant or not connected to public sewers with terminal facilities, the general standards
  as notified under the Environment (Protection) Act, 1986 shall be applicable.

Standards Of Micro waving

      1.   Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated
            animal carcasses, body parts and large metal items.
      2.  The microwave system shall comply with the efficacy tests/routine tests and a performance guarantee
            may be provided by the supplier before operation of the unit.
      3.  The microwave should completely and consistently kill bacteria and other pathogenic organism that is
            ensured by the approved biological indicator at the maximum design capacity of each microwave unit.
            Biological indicators for microwave shall be Bacillus Subtilis spores using vials or spore strips with a
            least 1*10⁴ spores per millilitre.

Standards For Deep Burial

      1.   A pit or trench should be dug about 2 m deep. It should be half filled with waste, then covered with
             lime within 50 cm of the surface, before filling the rest of the pit with soil.
      2.   It must be ensured that animals do not have access to burial sites. Covers of galvanised iron/wire
            meshes may be used.
      3.   On each occasion, when wastes are added to the pit, a layer of 10cm of soil be added to cover the
             wastes.
      4.   Burial must be performed under close and dedicated supervision.
      5.   The deep burial site should be relatively impermeable and no shallow well should be close
            to the site.
      6.   The pits should be distant from habitation, and sited so as to ensure that no contamination occurs
            of any surface water or ground water. The area should not be prone to flooding or erosion.
      7.   The location of the deep burial site will be authorised by the prescribed authority.
      8.   The institution shall maintain a record of all pits for deep burial.