3. Disposable bags, tubes and accessories for health care 098

Disposable bags, tubes and accessories for health care 098

Products that can be Nordic Swan Ecolabelled are disposable products and accessories for dialysis, intravenous infusion treatment, treatment of urinary retention and incontinence, blood bags and ostomy pouches.

A Nordic Swan Ecolabelled disposable product for healthcare meets strict chemical requirements. These include adhesive used in the product and additives to the plastic, such as plasticisers, dyes and antioxidants. Quality and safety requirements are set to ensure that the products are safe to use and work as intended. The requirements include:

  • Prohibition of the materials PVC and latex
  • The siloxanes D4, D5 and D6 is not allowed in silicone, but can be in the silicone as contaminants in limited amounts
  • Adding phthalates to the plastic is prohibited
  • Chemicals classified as environmentally harmful, toxic, allergenic, endocrine disruptors and CMR (carcinogenic, mutagenic, toxic for reproduction) cannot be added to the plastic or be part of the adhesive
  • Product and parts must comply with EU Medical Products Directive (2001/83 / EC) and/or Medical Devices Regulation (2017/745 / EU)

Below you will find all the necessary documents and background information to apply for the Nordic Swan Ecolabel.

    1. Start your application process by reading the criteria document and find out if your product can obtain the Nordic Swan Ecolabel. 
    2. Read your Application Guide.
    3. Request login credentials.
    4. Now you are ready to enter the Nordic Ecolabelling Portal.

     

    Portal sign in                               Get login credentials

     

    Should you wish to transfer your licence, please use this form. 

  • Fees valid from 1 January 2024

    Disposable bags, tubes, and instruments for medical use, including dialysis, drip, ostomy and urine bags.

    Type of fee Amount
    Application fee including one on-site inspection within the Nordic region *) 3 251 EUR + VAT 
    Renewal fee* 1 625 EUR + VAT
    More than one inspection visit within the Nordic region** 541 EUR + VAT per visit
    Inspection visits in Europe** 1 625 EUR + VAT per visit
    Inspection visits outside Europe** 2 709 EUR + VAT per visit
    Extension of existing licence*** Extension of existing or changes in licence

    < 4 hours: 406 EUR + VAT
    < 8 hours: 812 EUR + VAT
    ≥ 8 hours: 1 625 EUR + VAT

    Annual licence fee: The annual licence fee for the Nordic Swan Ecolabelled products is based on their turnover in the Nordic countries.

    		 0.3% of turnover + VAT from 0 – 30 million EUR 
    0.05% of turnover + VAT > 30 million EUR
    Minimum fee for Nordic region 2 167 EUR + VAT per year
    Maximum fee for Nordic region No maximum fee

    Fees for sale outside the Nordic region          
    (Only if revenue > EUR 300,000 per year)

    		 2 167 EUR + VAT per year

    * When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below 2 million EUR.

    ** Where audits requires more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1 083 EUR per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.

    *** As for an extension of or amendments to a licence, time consumed in connection with the review process will be invoiced according to the extent of the required task. We make a distinction between entirely administrative tasks that last less than 1 hour, and all other tasks that last between 1 and 4 hours, between 4 and 8 hours and more than 8 hours.

    The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC.
    All information given on this site is subject to a disclaimer for errors and omissions.

     

    Fees valid from 1 January 2023

    Disposable bags, tubes, and instruments for medical use, including dialysis, drip, ostomy and urine bags.

    Type of fee Amount
    Application fee including one on-site inspection within the Nordic region *) 3 114 EUR + VAT 
    Renewal fee* 1 557 EUR + VAT
    More than one inspection visit within the Nordic region** 519 EUR + VAT per visit
    Inspection visits in Europe** 1 557 EUR + VAT per visit
    Inspection visits outside Europe** 2 595 EUR + VAT per visit
    Extension of existing licence*** Extension of existing or changes in licence

    < 4 hours: 389 EUR + VAT
    < 8 hours: 778 EUR + VAT
    ≥ 8 hours: 1 557 EUR + VAT
    Annual licence fee for Nordic region 0.3% of turnover + VAT from 0 – 30 million EUR 
    0.05% of turnover + VAT > 30 million EUR
    Minimum fee for Nordic region 2 076 EUR + VAT per year
    Maximum fee for Nordic region No maximum fee

    Fees for sale outside the Nordic region          
    (Only if revenue > EUR 300,000 per year)

    		 2 076 EUR + VAT per year

    * When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below 2 million EUR.

    ** Where audits requires more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1 038 EUR per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.

    *** As for an extension of or amendments to a licence, time consumed in connection with the review process will be invoiced according to the extent of the required task. We make a distinction between entirely administrative tasks that last less than 1 hour, and all other tasks that last between 1 and 4 hours, between 4 and 8 hours and more than 8 hours.

    The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC.
    All information given on this site is subject to a disclaimer for errors and omissions.

  • In the criteria document, you can read about how to document and verify compliance for each requirement. You can also find other application documents here.

  • Information on the latest version of the criteria for disposable bags, tubes and accessories for health care

    2.4 ⇛ 2.5: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 24 months. The new version is called 2.5 and is valid until 31 Decenmber 2026.

    2.3 ⇛ 2.4: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 12 months. The new version, 2.4, is valid until 31 Decenmber 2024.

    2.2 ⇛ 2.3: Adjustment of criteria

    Requirement O5 and O6 have been adjusted. The new version, 2.3, is valid until 31 December 2023.

    2.1 ⇛ 2.2: Adjustment of criteria

    Requirement O5 has been adjusted. The new version, 2.2, is valid until 31 December 2023.

    2.0 ⇛ 2.1: Adjustment of criteria

    The criteria have been adjusted for exceptions for dyes classified as H317. The new version, 2.1, is valid until 31 December 2023.

    1.8 ⇛ 2.0: New criteria generation

    The criteria for disposable bags, tubes and accessories for health care have been revised. The new version, 2.0 is valid until 31 Decenmber 2023.

    1.7 ⇛ 1.8: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 6 months. The new version, 1.8, is valid until 31 Decenmber 2020.

    1.6 ⇛ 1.7: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R6 Recycling system, was removed. The new version, 1.7, is valid until June 30, 2020.

    1.5 ⇛ 1.6: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R7 Marketing, was removed. The new version, 1.6, is valid until March 31, 2019.

    1.4 ⇛ 1.5: Prolongation of the validity of the criteria

    The validity of Nordic Ecolabel's criteria for disposable bags, tubes and accessories for health care has been extended. The new version, 1.5, is valid until December 31, 2017.

  • In the background document below you will find reasoning and facts behind the specific requirements in the criteria document.

    Here you can also read the comments, requirement for requirement, from the public hearing.

    If the documents are in a Nordic language, you can get help in understanding the sections you need by contacting the product specialist in your chosen country below.