Criteria of the Seal for Own Bone and Own Tissue
Preamble
The seal represents a clear medical and ethical commitment: surgeons who carry this seal pledge without exception to perform all surgical procedures exclusively using the patient’s own bone and tissue. The seal applies to all surgical disciplines and is based on the principle of voluntary self-commitment.
§ 1 Scope of Application
1.1 These seal criteria apply to all surgeons across all surgical disciplines who apply for inclusion in the seal registry.
1.2 The seal relates exclusively to surgical procedures performed on humans in which bone or tissue material is transplanted, replaced, reconstructed, or otherwise utilized.
1.3 The criteria apply without restriction to all procedures performed by the Seal Holder in the course of their professional activity - regardless of institution, country, or circumstance of the procedure.
§ 2 Core Criterion - Exclusive Use of Autologous Material
2.1 The Seal Holder bindingly commits to refraining, in all surgical procedures without exception, from the use of the following materials:
∙ Foreign bone (allogenic bone grafts)
∙ Animal bone or tissue derivatives (xenogenic materials)
∙ Synthetic bone substitutes (e.g. hydroxyapatite, tricalcium phosphate, ceramics)
∙ Plastic implants or other non-autologous implants for tissue replacement
∙ Foreign tissue of any kind, including donor tissue and tissue bank material
2.2 The exclusive use of the following materials is permitted:
∙ Autologous bone (the patient’s own bone)
∙ Autologous tissue (the patient’s own tissue), including tendons, cartilage, fat, skin, muscle, and vessels
∙ Ceramic implants (Ceramic implants are only permitted as solid, prefabricated, and fully load-bearing implant components (e.g. ceramic femoral heads in hip arthroplasty or dental implants). The use of ceramic in granular, particulate, or paste form - including ceramic chips, ceramic granules, ceramic powder, or any ceramic bone substitute material - is expressly prohibited and does not fall within the scope of this permission.)
∙ Metallic implants made of pure titanium
2.3 This core criterion applies without exception. No exceptions exist, neither of a medical, logistical, nor organizational nature.
§ 3 Patient Informed Consent
3.1 The Seal Holder commits to informing every patient prior to the procedure in a comprehensive, understandable, and documentable manner that the planned procedure will be performed exclusively using autologous material.
3.2 The patient must be explicitly informed of:
∙ Which autologous material will be harvested
∙ The anatomical site from which the material will be taken
∙ The risks associated with the harvesting procedure
∙ What alternatives using non-autologous materials would theoretically exist and why the Seal Holder declines these
3.3 The informed consent process must be documented in writing and signed by the patient.
§ 4 Declaration of Self-Commitment
4.1 Inclusion in the seal registry requires the signing of the complete declaration of self-commitment. By signing, the Seal Holder acknowledges all seal criteria in their entirety and without reservation.
4.2 The declaration must be submitted truthfully and on the Seal Holder’s own responsibility. Any knowingly false statement shall result in immediate removal from the seal registry as well as possible legal consequences.
4.3 The declaration of self-commitment must be reconfirmed at any time upon request by the Operator.
§ 5 Professional Qualification
5.1 The seal may only be applied for by licensed physicians who have completed specialist training in a surgical discipline.
5.2 The Seal Holder is obligated to provide proof of their medical license and specialist qualification at any time upon request by the Operator.
5.3 Any revocation, suspension, or restriction of the medical license or specialist recognition shall automatically and without separate notification result in the immediate lapse of the seal entitlement.
§ 6 Communication and Representation of the Seal
6.1 The Seal Holder may use the seal exclusively in connection with their own person and their own surgical practice. Transfer to third parties, clinics, practices, or other institutions is not permitted.
6.2 The seal must not be used in any manner that creates the impression that it constitutes a governmental certification, regulatory approval, or recommendation by the Operator.
6.3 The Seal Holder commits to not using the seal in a misleading, exaggerated, or contextually incorrect manner.
§ 7 Reporting Obligations of the Seal Holder
7.1 The Seal Holder is obligated to notify the Operator immediately and without being prompted of:
∙ Any professional, regulatory, or criminal investigation or disciplinary proceedings relating to their surgical activity
∙ Any revocation or restriction of their medical license or specialist recognition
∙ Any permanent or temporary cessation of their surgical activity
∙ Any material change in their practice or hospital affiliation
§ 8 Revocation of the Seal
8.1 The Operator is entitled to revoke the seal with immediate effect and remove the Seal Holder from the registry if:
∙ There is a substantiated suspicion of a violation of the seal criteria
∙ The Seal Holder has knowingly submitted a false declaration of self-commitment
∙ The Seal Holder has breached a reporting obligation under § 7
∙ Professional, regulatory, or criminal measures have been initiated against the Seal Holder
∙ The Seal Holder’s conduct endangers the reputation of the seal
8.2 There is no entitlement to remain in the seal registry. Revocation of the seal does not give rise to any claims for damages against the Operator.
§ 9 Severability Clause
Should any provision of these seal criteria be or become wholly or partially invalid or unenforceable, the validity of the remaining provisions shall remain unaffected. The invalid provision shall be replaced by a valid provision that most closely approximates the purpose of the invalid provision.
§ 10 Right of Amendment
The Operator reserves the right to amend or supplement these seal criteria at any time. Seal Holders will be informed of material changes and must consent to them within a reasonable period. In the event of refusal, the seal entitlement shall lapse.
As of: May 2026