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January 10, 2026
Approximately 5 minutes
Slovakia Decree No. 158/2015 Annex 8: Requirements for Sterilisation Validation of Medical Devices
Slovakia Decree No. 158/2015 Annex 8: Requirements for Sterilisation Validation of Medical Devices
1. Legal Basis and Scope
Annex 8 (Príloha č. 8) to Decree No. 158/2015 Z.z. details the sterilisation validation obligations for sterile medical devices (including sterile Class I, IIa, IIb, III) under the Slovak transposition of Directive 93/42/EEC (MDD) Annex I essential requirements 8.3–8.6. It applies to all devices claiming sterility and remains relevant for legacy sterile devices during the MDR transitional period (Regulation (EU) 2017/745 Article 120). Source: Decree No. 158/2015 Z.z. Annex 8 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
2. Sterilisation Methods Covered
The annex covers common terminal sterilisation methods:
- Ethylene oxide (EO/EtO)
- Moist heat (steam autoclaving)
- Dry heat
- Radiation (gamma, electron beam, X-ray)
- Other validated methods (e.g., hydrogen peroxide plasma, ozone)
Aseptic processing is addressed with stricter controls where terminal sterilisation is not feasible. Source: Decree No. 158/2015 Z.z. Annex 8 method provisions (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
3. Validation Requirements
Manufacturers must demonstrate:
- Process validation per harmonised standards (EN ISO 11135 for EO, EN ISO 17665 for moist heat, EN ISO 11137 for radiation)
- Achievement of sterility assurance level (SAL) ≤ 10⁻⁶
- Bioburden monitoring and control
- Worst-case product loading and cycle parameters
- Physical, chemical and biological indicators validation
Validation data must be part of the technical documentation. Source: Decree No. 158/2015 Z.z. Annex 8 validation section (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
4. Packaging and Labelling Obligations
- Sterile barrier system must maintain sterility until point of use
- Packaging validation required (EN ISO 11607 series)
- Labelling must include: “STERILE”, method symbol (e.g., radiation symbol), “Do not re-sterilise” if applicable, lot/batch/expiry
- Slovak language mandatory for end-user labelling
Source: Decree No. 158/2015 Z.z. Annex 8 packaging/labelling (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
5. Routine Monitoring and Revalidation
- Routine release testing (biological indicators, parametric release)
- Annual revalidation or after significant changes (equipment, load, process parameters)
- Ongoing bioburden trend monitoring
- Change control impacting sterilisation requires revalidation
Source: Decree No. 158/2015 Z.z. Annex 8 monitoring/revalidation (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
6. MDR Transition Considerations
Legacy sterile devices follow Annex 8 until MDD certificate expiry. Under full MDR:
- Stricter validation per MDR Annex I Section 10.4–10.8
- Notified body involvement for sterile Class IIa and higher
- EUDAMED registration of sterilisation details
Source: Decree No. 158/2015 Z.z. Annex 8 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
7. RA Manager Practical Guidance
- Map device to appropriate ISO standard for method
- Document worst-case validation rationale
- Maintain bioburden data trending
- Prepare Slovak sterile labelling templates
- Schedule annual revalidation calendar
- Integrate sterilisation change control in QMS
Source: Decree No. 158/2015 Z.z. Annex 8 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
8. Common Validation Pitfalls
- Inadequate bioburden sampling plan
- Missing SAL justification for non-standard methods
- Packaging integrity not validated to real shelf-life
- No revalidation after equipment upgrades
- Incomplete parametric release data
Source: Decree No. 158/2015 Z.z. Annex 8 practical notes (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
9. ŠÚKL Expectations During Registration
ŠÚKL reviews sterilisation validation as part of higher-risk device submissions (Annex 3 Part B). Deficiencies may delay registration or trigger additional data requests. Source: Decree No. 158/2015 Z.z. Annex 8 in context of Annex 3 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
10. Alignment with Harmonised Standards
Annex 8 references key standards:
- EN ISO 11135 (EO)
- EN ISO 17665 (moist heat)
- EN ISO 11137 (radiation)
- EN ISO 11607 (packaging)
Compliance with current versions is expected. Source: Decree No. 158/2015 Z.z. Annex 8 (https://www.slov-lex.sk/ezbierky/pravne-predpisy/SK/ZZ/2015/158/20151215#prilohy.priloha-priloha_c_8_k_vyhlaske_c_158_2015_z_z.oznacenie)
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